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Accuray, Inc.

United StatesFDA applicant, unverified

Devices
10
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue10

Newest first, rows 1-10 of 10

FDA recalls13

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

Showing the 10 most recent of 13 recalls.

  • 2010

    • 28 Oct 2010 Z-0714-2011 Unclassified (pre-2012) Terminated If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated. Distribution: USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea,…
      Full distribution text USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.
      Submission number: K091999
    • 6 Jul 2010 Z-0890-2011 Unclassified (pre-2012) Terminated Latches responsible for securing the cover to the device may come lose if not properly secured and the cover may unexpectedly drop off. A design change is planned. Distribution: Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND,…
      Full distribution text Worldwide distribution: US including: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV, and countries including: Japan, China, Vietnam, Taiwan/China, South Korea, Hong Kong/China, Thailand and Malaysia.
      Submission number: K091146
    • 15 Jan 2010 Z-1023-2011 Unclassified (pre-2012) Terminated When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available. Distribution: Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands…
      Full distribution text Worldwide Distribution: USA and countries including: Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong.
      Submission number: K091146

  • 2009

    • 29 Dec 2009 Z-1008-2011 Unclassified (pre-2012) Terminated If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment. Distribution: Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK,…
      Full distribution text Worldwide Distribution: USA and countries including: Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China.
      Submission number: K091146
    • 21 Jul 2009 Z-0853-2011 Unclassified (pre-2012) Terminated Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. Distribution: Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of…
      Full distribution text Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.
      Submission numbers: K042146, K072504
    • 22 Jun 2009 Z-1810-2009 Unclassified (pre-2012) Terminated Targeting accuracy out of specification, Error alert does not render the system down, which may result in mistreatment in the wrong area. Distribution: Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI,…
      Full distribution text Worldwide Distribution -- US including states of MA, FL, AL, TN, DE, CA, NJ, OK, CO, NC, IL, PA, MD, DC, MS, CN, NV, RI, SC, UT, VA, MI, NE, MO, TX and AL and countries of Canada, Russia, UK, Ukraine, Saudi Arabia, Switzerland, Turkey, Taiwan, India, China, Korea and Thailand.
      Submission number: K072504
    • 16 Mar 2009 Z-0908-2011 Unclassified (pre-2012) Terminated The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK,…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
      Submission numbers: K020294, K072504
    • 16 Mar 2009 Z-0909-2011 Unclassified (pre-2012) Terminated The product has the potential for the extension coupling of the Synchrony extension mounting hardware to become loose over time. The assembly weighs approximately 17 pounds; an unexpected contact with users or patients may result in serious injury if the boom descends unexpectedly. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK,…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries of Turkey, Russia, France, Italy, the Netherlands, the UK, Spain, Greece, Switzerland, Germany, India, Taiwan, China, Hong Kong, Korea, Thailand, Malaysia and Japan
      Submission numbers: K020294, K072504

  • 2008

    • 14 Nov 2008 Z-0629-2009 Unclassified (pre-2012) Terminated System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury. Distribution: Nationwide Distribution. Product was distributed to 4 medical facilities in the US. Submission number: K072504
    • 30 Oct 2008 Z-0856-2009 Unclassified (pre-2012) Terminated Product may not be tensioned properly, potentially causing unexpected rotation or descent. Distribution: Worldwide Distribution --- including USA and countries of France and Turkey. Submission number: K042146
Show all 13 recalls

  • 2008

    • 1 May 2008 Z-1862-2008 Unclassified (pre-2012) Terminated Couch may move unexpectedly, which may result in patient impacting the linear accelerator. Distribution: Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam,…
      Full distribution text Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.
      Submission number: K072504
    • 9 Apr 2008 Z-2056-2008 Unclassified (pre-2012) Terminated Sample beam data (which should not be used to treat patients) may differ from actual radiation output of an installed product, and which may be used by users. Distribution: Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey,…
      Full distribution text Product was distributed to 104 medical centers throughout the US and to Vietnam, China, Korea, Taiwan, Malaysia, Turkey, France, Italy, Spain, Greece and Germany.
      Submission number: K072504

  • 2007

    • 21 Mar 2007 Z-0364-2008 Unclassified (pre-2012) Terminated Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. Distribution: Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and…
      Full distribution text Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.
      Submission number: K052325

Frequently asked questions

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

The registry currently lists 10 devices for Accuray, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Accuray, Inc.'s devices?

Among its 10 most recently registered devices, Accuray, Inc. has devices listed in FDA 510(k) (10 devices).

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

Among its 10 most recently registered devices, the classes recorded for Accuray, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Accuray, Inc.?

FDA recall records list 13 recalls initiated by Accuray, Inc., the most recent initiated on 28 Oct 2010. 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 Accuray, Inc. in the registry?

The most recently registered devices listed for Accuray, Inc. include THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1, MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM, CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY and CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY.

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