Siemens Medical Solutions USA, Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model 4504200
Products Sold
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
Siemens Medical Solutions USA, Inc is recalling Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation due to Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AR, CA, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, WV, WI, WY
Page updated: Jan 10, 2026