Terminated

TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). .

FDA Recall Z-2239-2014 · Posted 2014-08-15

Recalling FirmTomoTherapy Incorporated

Recall StatusTerminated

Product CodeIYE

Date Initiated2014-07-17

Date Terminated2015-09-08

Product Quantity322

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.

Firm Action

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 [email protected]

Root Cause

Software design

Distribution Pattern

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,OK, OR, PA, SC, SD, TX, UT, VA, WV, and WI, and the countries of AUSTRALIA, BELGIUM CANDA, CHINA, EL SALVADOR, ENGLAND, FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NETHERLANDS, PHILIPPINE, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121934TOMOTHERAPY TREATMENT SYSTEMAccuray Incorporated · 2012-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.