—#66451

Product

Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Model number 1940035, Serial Numbers 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323

Why it was recalled

Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

Root cause (FDA determination)

Device Design

Action the firm took

The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.

Timeline

Recall initiated: 2007-03-23
Posted by FDA: 2007-12-01
Terminated: 2011-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66451. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.