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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron M2 Primus MidEnergy

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 Class 2 Device Recall Mevatron M2 Primus MidEnergysee related information
Date Initiated by FirmMarch 23, 2007
Date PostedDecember 01, 2007
Recall Status1 Terminated 3 on February 11, 2011
Recall NumberZ-0384-2008
Recall Event ID 38345
Product Classification Linear Accelerator - Product Code IYE
ProductSiemens, 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
Code Information Model number 1940035, Serial Numbers 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323 
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information Contact
925-246-8407
Manufacturer Reason
for Recall		Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
FDA Determined
Cause 2		Device Design
ActionThe 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.
Quantity in Commerce9 units.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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