TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2
FDA device recall Z-2239-2014 · posted 2014-08-15 · Terminated
Recall details
- Recalling firm
- TomoTherapy Incorporated
- Reason for recall
- Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.
- Action taken
- Consignees were sent an Accuray "Urgent Device Correction" letter dated July 16, 2014. The letter was addressed to TomoTherapy System Medical Physicist. The letter described the Purpose of this letter, Description of the Potential Problems, Safety Instructions and software upgrade information. For questions or concerns they can 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
- 322
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL, GA, HI, IL IN, IA, KS,KY, LA, MD, MA, MI, MO, MT, NE, NV, NJ, NM, NY, NC,ND, OH,
- Date initiated
- 2014-07-17
- Date posted
- 2014-08-15
- Date terminated
- 2015-09-08
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOMOTHERAPY TREATMENT SYSTEM (K121934) | Accuray Incorporated | 2012-08-29 |