Recalls / —

—#163344

Product

ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 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

K121295

Affected lot / code info

Serial no: 3855 4019 4067 3953 5148 3793 5098 5222 3801 5388 3948 3755 5033 4015 5095

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 #163344. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.