Recall Z-2240-2014 ยท IYE Accelerator, Linear, Medical
TomoTherapy Incorporated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delive
| Date | Aug 15, 2014 (initiated Jul 16, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121934 | TOMOTHERAPY TREATMENT SYSTEM Accuray Incorporated, Aug 29, 2012 |