—#53464

Product

Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical 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
510(k) numbers: K031764, K993425
Affected lot / code info: Model 4504200, Serial Numbers 3672 3675 3695 3727 3728 3751 3773 2931 2941 3002 3042 3068 3158 3191 3212 3244 3257 3273 3276 3382 3406 3407 3418 3424 3443 3489 3492 3504 3515 3516 3547 3564 3578 3579 3583 3587 3592 3597 3638 3641 3663 3666 3667 3825 3835 3919 3949 3994 4004 4036 4061 4232 70-4117 70-4126 70-4133 70-4139 70-4141 70-4185 70-4218 70-4219 70-4279 70-4282 70-4285 70-4308

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 #53464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.