Siemens Medical Solutions USA, Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model number 1940035, Serial Numbers 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323
Products Sold
Model number 1940035, Serial Numbers 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323
Siemens Medical Solutions USA, Inc is recalling Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation thera 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