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Computerized Medical Systems, Inc.

United StatesFDA applicant, unverified

Devices
23
FDA recalls
32

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Computerized Medical Systems, Inc. makes

Computerized Medical Systems, Inc. manufactures radiation therapy planning and delivery systems, including radiation treatment planning (RTP) workstations like the FOCUS and XIO systems, beam data acquisition systems, and specialized adapters such as the RECORD AND VERIFY MEVATRON ADAPTER. Their portfolio also includes contouring workstations (e.g., FOCUS PILOT) and compensating filters designed to enhance precision in radiation oncology workflows.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the U.S. regulatory database, adhering to FDA requirements for medical radiation devices.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue23

Newest first, rows 1-23 of 23

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  • Focus Ref K002147

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Monaco Rtp System Ref K110730

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Enhanced Compensating Filter Ref K000137

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focus Rtp System Ref K973936

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • I-Beam Ref K032100

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Record And Verify Mevatron Adapter Ref K913674

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focus Radiation Treatment Planning System Ref K020027

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Radiation Beam Data Acquistioin Systems Ref K854880

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xio Rtp System Ref K092132

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focus Rtp Ref K915691

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xio Rtp System Ref K102216

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focus Pilot Contouring Workstation Ref K981535

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cms Record And Verify Ref K921108

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Life-Watch Monitor Lt-8 Ref K863534

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Monaco Rtp System Ref K071938

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cms Record And Verify System Ref K882484

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Life-Trace 18 Single-Trace Cardiac Monitor/Record. Ref K863535

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Atlas-Based Autosegmentation Ref K080799

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Xio Radiation Treatment Planning System Ref K032762

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modulex Rtp System Ref K913017

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Focal Sim Ref K013112

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Computerized Radiation Treatment Planning Sys Ref K853964

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Monaco Rtp System, Vmat Option Ref K091179

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-23 of 23

FDA recalls32

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 32 recalls initiated by Computerized Medical Systems, Inc., the earliest on 2006-11-09 and the most recent on 2012-04-30. By recorded status: 32 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 32 recalls.

  • 2012

    • 30 Apr 2012 Z-1644-2012 Not yet classified Terminated XiO will underestimate the dose delivered when the closed leaf gap is set to 0mm on XiO and a value other than 0mm is set on the accelerator. Distribution: Worldwide Distribution - USA (nationwide) and the country of Canada Submission number: K102216
    • 5 Mar 2012 Z-1365-2012 Not yet classified Terminated An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose. Distribution: Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries…
      Full distribution text Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the United Kingdom.
      Submission number: K110730

  • 2011

    • 9 Jun 2011 Z-2919-2011 Unclassified (pre-2012) Terminated The XiO Software currently prompts for entry of CT to ED data for a studyset. No indication is given that the Electron Density data should only be used for Photon and Electron calculations and either Relative Stopping Power or Mass Density should be used for Proton calculations (depending on the algorithm). Distribution: Worldwide distribution: USA (nationwide) including: IL, IN, MA, NJ and OK; and country of Germany. Submission number: K102216
    • 13 Jan 2011 Z-2561-2011 Unclassified (pre-2012) Terminated Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00. Distribution: Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech…
      Full distribution text Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.
      Submission numbers: K071938, K091179
    • 13 Jan 2011 Z-2598-2011 Unclassified (pre-2012) Terminated Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report. Distribution: Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR,…
      Full distribution text Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.
      Submission numbers: K071938, K091179

  • 2010

    • 16 Nov 2010 Z-2582-2011 Unclassified (pre-2012) Terminated XiO: When a new electron beam is added to a plan, the calculation Algorithm is set to Pencil Beam, and an Aperture is added to the beam, the user can select Port-Port Properties and edit the Material Thickness values. If the algorithm is then changed to Monte Carlo, the calculation will proceed and the user is not warned the Material/Thickness values just entered are not used in the dose calculati Distribution: Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria,…
      Full distribution text Worldwide Distribution - USA (nationwide, Washington, DC and Puerto Rico and the countries of Albania, Algeria, Australia, Austria, Bahamas, Belarus, Belgium, Brazil, Canada, Chile, China,Croatia, Cyrus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Phillipines,Poland, Portugal, Romoania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Suriname, Switzerland, Taiwan, Thailand, Turkey, Turmenistan, Ukraine, United Kingdom, and Vietnam
      Submission number: K102216
    • 9 Nov 2010 Z-2562-2011 Unclassified (pre-2012) Terminated Focal: If a plan involving Dynamic MLC Delivery is sent from XiO to Focal and called up there in Plan Review, the angle of the gantry is set to zero for all beams. If this plan is then sent from Focal to the R&V System, the gantry angles all remain at zero which could lead to patient mistreatment. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada,…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Belarus, Belgium, Brazil, Canada, Chile, China, Egypt, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Latvia, Libya, Lithuania, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Romania, Singapore, Slovenia, South Africa, Spain, Suriname, Switzerland, Taiwan, Turkey, Turkmenistan, and the United Kingdom.
      Submission number: K013112
    • 27 Oct 2010 Z-2569-2011 Unclassified (pre-2012) Terminated Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero. Distribution: Worldwide Distribution - USA including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands. Submission numbers: K071938, K091179
    • 3 Oct 2010 Z-2579-2011 Unclassified (pre-2012) Terminated XiO: When the beam template is recalled, XiO prematurely initiates a dose calculation, re-snaps the MLC or Port to the structure of the current patient , but then fails to re-calculate dose for the new MLC or Port position. If no subsequent change is made to force a dose recalculation, XiO will display the dose from the original MLC/Port shape dose instead of the dose from the re-snapped MLC/Port Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia,…
      Full distribution text Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132
    • 17 Sep 2010 Z-2578-2011 Unclassified (pre-2012) Terminated When a dialog box is displayed and the dose status is changed to "Dose not current", beam edits can be made in the graphics area using the mouse (rotate collimator, reposition collimator, move isocenter, move weight point, etc.). Then if CANCEL is selected on the dialog box, any edits made on the dialog box are undone, the dose is left unchanged, but the beam edits made in the graphics area with t Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico, and countries of: Albania, Algeria, Argentina,…
      Full distribution text Worldwide distribution: USA (nationwide) including Puerto Rico, and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092163
Show the 25 most recent of 32 recalls

  • 2010

    • 10 Sep 2010 Z-2408-2011 Unclassified (pre-2012) Terminated When RT Plans are exported from XiO and RT Structure Sets and Images are exported from Monaco, the DICOM iso-center coordinates may not be accurate. Distribution: Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia,…
      Full distribution text Worldwide Distribution - USA (nationwide and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132
    • 31 May 2010 Z-2564-2011 Unclassified (pre-2012) Terminated Monaco: due to a software defect, the Radiological Depth (cm) and SSD to DRP (cm) parameters are reported incorrectly on the Beam Summary Report. This occurs for all Monaco IMRT plans. Distribution: Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France,…
      Full distribution text Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom.
      Submission numbers: K071938, K091179
    • 28 May 2010 Z-2595-2011 Unclassified (pre-2012) Terminated XiO Software: when Digitally Reconstructed Radiographs (DRRs) are generated in XiO, and DICOM is used to export the DRRs (File-Print-DRR), the exported images are associated with the Beams, but NOT the Plan. The Plan association had always been done manually by the user. This is functionality that has never been provided on XiO. The problem occurs because XiO is not storing a persistent DICOM Distribution: Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) and the countries of…
      Full distribution text Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132
    • 27 May 2010 Z-2407-2011 Unclassified (pre-2012) Terminated XiO Software: For a specific clinical setup, the MLC leaf positions on the exported DRR images might not match the MLC leaf positions displayed in XiO. Distribution: Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and…
      Full distribution text Nationwide distribution, including Puerto Rico, to medical facilities. Distribution was also made to Military and Government consignees. Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, and United Kingdom.
      Submission number: K092132
    • 27 May 2010 Z-2593-2011 Unclassified (pre-2012) Terminated XiO Software: The Patient Scan position is being confused with the treatment orientation of the patient. The Patient Scan position is determined from the data entered in PFM. Subsequently, when a New Teletherapy Plan is created for a patient in Teletherapy, the user is prompted with Head/Foot Gantry on the text page. This prompt is asking for the orientation of the patient when they are treated. Distribution: Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution…
      Full distribution text Worldwide Distribution - USA (Nationwide distribution, including Washington, DC and Puerto Rico) Foreign distribution was made to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132
    • 19 May 2010 Z-2604-2011 Unclassified (pre-2012) Terminated XiO Software: when a treatment machine is defined in Source File Maintenance (SFM), the MLC Model is set to Elekta, and beams using this treatment machine are added to a new plan in Teletherapy, XiO automatically adds an MLC to the beam. This is because the Elekta linac will always have an MLC in place when the plan is actually delivered. Distribution: Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and…
      Full distribution text Nationwide distribution to medical facilities including Puerto Rico. Distribution was also made to two Military and Government consignees. Foreign distribution was made to Australia, Belgium, Brazil, Canada, Colombia, France, India, Ireland, Israel, Italy, Malaysia, Netherlands, Philippines, Poland, Spain, and United Kingdom.
      Submission number: K092132
    • 10 May 2010 Z-2592-2011 Unclassified (pre-2012) Terminated Focal: for XiO plans calculated in relative dose mode, the Focal Plan Review application will display the DVH and maximum dose correctly. However, the isodose display is not scaled correctly. If the user evaluated the plan based only on the isodose display, they might misinterpret the actual dose delivered to the patient. Distribution: Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia,…
      Full distribution text Worldwide Distribution - USA (Nationwide including Puerto Rico) Foreign distribution was made to Albania, Australia, Austria, Belgium, Canada, Chile, China, Cyprus, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Russia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkmenistan.
      Submission number: K013112
    • 15 Apr 2010 Z-1655-2010 Unclassified (pre-2012) Terminated Under certain circumstances, XiO will over-estimate dose in the region where the backup jaw is inside the MLC opening Distribution: Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France,…
      Full distribution text Worldwide Distribution: USA, Canada, Australia, Spain, Italy, the Netherlands, United Kingdom, Taiwan, Malaysia, France, Ireland, and Israel.
      Submission number: K092132
    • 22 Feb 2010 Z-1209-2010 Unclassified (pre-2012) Terminated Inconsistent MLC positions, dose, and monitor units Distribution: Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and…
      Full distribution text Worldwide Distribution -- United States (PA, AZ, CA, MN, OH, WI, NC, FL, TX, NY and WI), Australia, The Netherlands and India.
      Submission number: K092132

  • 2009

    • 11 Dec 2009 Z-2645-2011 Unclassified (pre-2012) Terminated ERGO Release 1.6.3 is overestimating the MU values. Distribution: Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was…
      Full distribution text Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malaysia, Poland, Portugal, Serbia, and Spain.
      Submission number: K080601
    • 12 Jun 2009 Z-2559-2011 Unclassified (pre-2012) Terminated Focal Software: When a patient is defined as prone and the shifts are manually entered and the LOCK SHIFT box is checked the X coordinate (left/right) and the Z coordinate (anterior/posterior) are reversed (left to right, anterior to posterior). This could potentially lead to incorrect isocenter definitions from prone patients and thus a mislocation of dose. Distribution: Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria,…
      Full distribution text Worldwide Distribution -- USA (nationwide) including Puerto Rico, and the countries of Algeria, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, Nicaragua, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, and Venezuela.
      Submission number: K013112
    • 13 May 2009 Z-2568-2011 Unclassified (pre-2012) Terminated In XiO, when the beams are renumbered, it is possible to get into a state where the dose displayed for a beam does not match the beam placement on the patient. This can occur when dose is calculated, beams are renumbered, and the dose is re-summed only. Distribution: Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria,…
      Full distribution text Worldwide Distribution -- (USA) nationwide Distribution, including Puerto Rico, and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia, Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Libya, Lithuania, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132
    • 6 Feb 2009 Z-2599-2011 Unclassified (pre-2012) Terminated Focal Software: if individual MLC leaf position edits are made, the original MLC aperture is retained. A subsequent aperture edit should not affect the MLC leaf positions however it was found that instead the leaves will then snap (unintentionally) back to the original aperture. Also, if the patient is sent to XiO after the MLC is edited, an isocenter shift made in XiO will also cause the MLCs to Distribution: Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria,…
      Full distribution text Worldwide Distribution -- USA (nationwide) including the state of: Puerto Rico and countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Mongolia, Morocco, Netherlands, New Zealand, Nicaragua, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sudan, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Kingdom, Uruguay and Venezuela.
      Submission number: K013112
    • 19 Jan 2009 Z-2594-2011 Unclassified (pre-2012) Terminated Focal: the couch position can be moved between scans of the same CT study. When the images are imported into Focal, the software is not checking the DICOM Image Position (Patient) tag and therefore is not aligning the images sets if there are different couch positions indicated. A shift between image sets will exist of the same amount that the CT couch was moved. Distribution: Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA.…
      Full distribution text Worldwide Distribution -- USA (nationwide) including states of: CA, CO, FL, IL, IN, KS, MO, NC, OH, OK, PA, TN, and WA. and countries of Australia, Austria, Canada, India, Netherlands, Portugal, Singapore, Spain, and United Kingdom.
      Submission number: K013112

  • 2008

    • 9 Dec 2008 Z-2567-2011 Unclassified (pre-2012) Terminated XiO Software: Under certain conditions, when the port shape is altered, dose is not recalculated. The port-change flag is not being set correctly when the port shape is regenerated. The dose distribution will not match the blocking displayed and the mis-match might not be obvious. Monitor Unit calculations will also be based on an incorrect dose distribution. This problem has existed since Re Distribution: Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia,…
      Full distribution text Worldwide Distribution-- USA (nationwide) including Puerto Rico and countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Nicaragua, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Tajikistan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe.
      Submission number: K092132

Frequently asked questions

How many devices does Computerized Medical Systems, Inc. have in the registry?

The registry currently lists 23 devices for Computerized Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Computerized Medical Systems, Inc.'s devices?

Among its 23 most recently registered devices, Computerized Medical Systems, Inc. has devices listed in FDA 510(k) (23 devices).

What risk classes do Computerized Medical Systems, Inc.'s devices fall under?

Among its 23 most recently registered devices, the classes recorded for Computerized Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Computerized Medical Systems, Inc.?

FDA recall records list 32 recalls initiated by Computerized Medical Systems, Inc., the most recent initiated on 30 Apr 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Computerized Medical Systems, Inc. in the registry?

The most recently registered devices listed for Computerized Medical Systems, Inc. include FOCUS, MONACO RTP SYSTEM, ENHANCED COMPENSATING FILTER and FOCUS RTP SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.