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U.S. Department of Health and Human Services

Class 2 Device Recall Mevatron M2/PRIMUS Plus

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  Class 2 Device Recall Mevatron M2/PRIMUS Plus see related information
Date Initiated by Firm March 23, 2007
Date Posted December 01, 2007
Recall Status1 Terminated 3 on February 11, 2011
Recall Number Z-0380-2008
Recall Event ID 38345
510(K)Number K993425  K031764  
Product Classification Linear Accelerator - Product Code IYE
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
Code Information 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
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
Action 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.
Quantity in Commerce 64 units
Distribution 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.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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