TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
FDA device recall Z-0507-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
- Action taken
- Accuray sent an "Urgent Field Safety Notice" dated November 21, 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customers. For questions they can contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com>Services & Support or call: North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong: +852.2247.8688, Japan: +81.3.6269.9556. Requested consignees to complete and return the Acknowledgement Form to Accuray Regulatory Affairs.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 210 ( 72 USA; 138 OUS )
- Distribution
- Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries
- Date initiated
- 2014-11-21
- Date posted
- 2014-12-12
- Date terminated
- 2015-07-17
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOMOTHERAPY TREATMENT SYSTEM (K121934) | Accuray Incorporated | 2012-08-29 |