TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art
FDA device recall Z-2240-2014 · posted 2014-08-15 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
- Action taken
- Accuray sent an "Urgent Device Correction" letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. These anomalies will be corrected with a new software version. You will be contacted by Accuray Customer Support to schedule a software upgrade to your system. If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1.877.668.8667 (USA) or +1.408.716.4700 (non-USA) or customersupport@accuray.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 168 (75 US; 93 OUS)
- Distribution
- Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM,
- Date initiated
- 2014-07-16
- Date posted
- 2014-08-15
- Date terminated
- 2015-07-21
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOMOTHERAPY TREATMENT SYSTEM (K121934) | Accuray Incorporated | 2012-08-29 |