—#163342

Product

ONCOR Expression, Digital Linear Accelerator, Model No. 07360717 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: Serial no: 5245 5353

Why it was recalled

Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.

Root cause (FDA determination)

Software design

Action the firm took

On February 16, 2018, the recalling firm issued a Customer Advisory Notice via USPS Certified Mail to inform customers about the update of the Control Console software version 9.2.400 of the Digital Linear Accelerator to version 9.2.502. Customers were informed of the issues that would be fixed through this software update. Consignees were asked to instruct affected personnel accordingly, place the safety advisory notice in the device's instructions for use, and have personnel maintain awareness until the fix is implemented.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

Timeline

Recall initiated: 2018-02-14
Terminated: 2019-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163342. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.