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Sonosite, Inc.

United StatesFDA applicant, unverified

Devices
22
FDA recalls
10

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sonosite, Inc. makes

Sonosite, Inc. manufactures portable and hand-carried ultrasound systems, including diagnostic and high-resolution models for general imaging, echocardiography (e.g., SONOHEART), and catheter guidance (e.g., LUMENVU). Their portfolio also includes specialized systems like the TITAN series for high-resolution imaging and the NANOMAXX series for compact, mobile use.

All listed devices fall under Class II regulatory classification in the US and are recorded in the FDA 510(k) database. The company is based in the United States.

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

Catalogue22

Newest first, rows 1-22 of 22

Search and filter all 22 devices
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Rows 1-22 of 22

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 10 recalls initiated by Sonosite, Inc., the earliest on 2005-10-26 and the most recent on 2013-09-11. By recorded status: 10 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, sterility or contamination, electrical or power and performance or accuracy. 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.

  • 2013

    • 11 Sep 2013 Z-0027-2014 Class II Terminated FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is not working as intended. Distribution: Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas,…
      Full distribution text Worldwide Distribution - USA Nationwide in the states of Florida, Georgia, Oklahoma, Pennsylvania, Tennessee, Texas, West Virginia, and in the country Japan and Italy.
      Submission numbers: K113156, K130173

  • 2011

    • 18 Jul 2011 Z-0057-2012 Unclassified (pre-2012) Terminated This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment. Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa,…
      Full distribution text Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Afghanistan, Algeria, American Samoa, Argentina, Australia, Bolivia, Botswana, Brazil, Canada, China, Costa Rica, Cyprus, Dominican Republic, Estonia, France, Gambia, Germany, Great Britain, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Mauritius, Mexico, Netherlands, New Zealand, Nigeria, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Tanzania, Uganda, United Arab Emirates, Viet Nam, and Zambia.
      Submission numbers: K043559, K053069, K071134, K082098

  • 2010

    • 13 Aug 2010 Z-0478-2011 Unclassified (pre-2012) Terminated Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect. Distribution: Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New…
      Full distribution text Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
      Submission number: K092058
    • 27 May 2010 Z-2116-2010 Unclassified (pre-2012) Terminated PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment. Distribution: Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia. Submission numbers: K053069, K082098, K092058

  • 2008

    • 8 Aug 2008 Z-2191-2010 Unclassified (pre-2012) Terminated The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array. Distribution: Worldwide distribution: USA and countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech…
      Full distribution text Worldwide distribution: USA and countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Iran, Ireland, Israel, Italy, Korea, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Switzerland, and Thailand.
      Submission number: K071134

  • 2007

    • 2 Nov 2007 Z-2654-2010 Unclassified (pre-2012) Terminated Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer. Distribution: Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX,…
      Full distribution text Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
      Submission number: K043559
    • 2 Nov 2007 Z-2655-2010 Unclassified (pre-2012) Terminated Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer. Distribution: Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX,…
      Full distribution text Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.
      Submission number: K043559
    • 5 Feb 2007 Z-0661-2007 Unclassified (pre-2012) Terminated Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db. Distribution: Distribution to USA (Tennessee & Ohio), France, Korea, and Germany. Submission numbers: K043559, K053069

  • 2005

    • 12 Dec 2005 Z-0407-06 Unclassified (pre-2012) Terminated 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. Distribution: Product was distributed to distributors and hospitals nationwide and internationally. Submission number: K030064
    • 26 Oct 2005 Z-0713-06 Unclassified (pre-2012) Terminated When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Underestimates percentage of stenosis, false negative result. Distribution: Nationwide, Kuwait, Mexico, South Africa, Chile, Spain, Japan, Puerto Rico, Australia. A list of 155 cases in which the…
      Full distribution text Nationwide, Kuwait, Mexico, South Africa, Chile, Spain, Japan, Puerto Rico, Australia. A list of 155 cases in which the software was sent out lists medical facilities, physicans, and SonoSite Distributors.
      Submission number: K030223

Frequently asked questions

How many devices does Sonosite, Inc. have in the registry?

The registry currently lists 22 devices for Sonosite, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sonosite, Inc.'s devices?

Among its 22 most recently registered devices, Sonosite, Inc. has devices listed in FDA 510(k) (22 devices).

What risk classes do Sonosite, Inc.'s devices fall under?

Among its 22 most recently registered devices, the classes recorded for Sonosite, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sonosite, Inc.?

FDA recall records list 10 recalls initiated by Sonosite, Inc., the most recent initiated on 11 Sep 2013. 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 Sonosite, Inc. in the registry?

The most recently registered devices listed for Sonosite, Inc. include SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES), SONOSITE HAND-CARRIED ULTRASOUND SYSTEM, C1 ULTRASOUND SYSTEM and TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM.

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