Recalls / —

—#101290

Product

ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemnath, Germany. Distributed by Siemens Medical Solutions, Concord, CA 94520. Product Usage: Linear Accelerators used to deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K060226, K072485, K993425

Affected lot / code info

Therapist Express Basic, Part Number 08151289; Therapist Express Assist, Part Number 08151297; syngo RT Therapist Assist, Part Number 08162807; syngo RT Therapist, Part Number 08162815; syngo RT Therapist Connect/MOSIAQ OIS, Part Number 08168754.

Why it was recalled

A potential safety issue was discovered when a pause for an imaging segment is inserted (where an imaging segment does not exist) with the ARTISTE and RT Therapist 4.1 system will continue to the next image.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent an "Urgent: Medical Device Correction/ Customer Safety Advisory Notice" letter to all affected customers starting June 3, 2011. The letter describes the product, problem, and instructions to prevent mistreatment. The letter states that Siemens is working on an updated version of RTT 4.1 that will fix the issues. Users will be notified as soon as the update for the system is available. The customers were instructed to include Customer Safety Advisory notice in their syngo RT Therapist 4.1 System Owner Manual chapter "Safety Advisory Letters" where it should remain.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

Worldwide Distribution - USA (nationwide) including the states of: DE, FL, KY, LA, MA, MI, MO, NE, NJ, OH, PA, TN, WI, UT, WV and Puerto Rico and the countries of: Australia, Belgium, Brazil, Canada, China, Egypt, France, Germany, Hungary, India, Ireland, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Russian Fed, Saudi Arabia, South Africa, Norway, Spain, Turkey and United Kingdom.

Timeline

Recall initiated

2011-06-03

Posted by FDA

2011-08-11

Terminated

2012-02-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #101290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.