Z-0380-2008

Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy...

Name: Z-0380-2008 Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-03-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-03-23 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel... on 2007-03-23. The reason FDA records is "Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0380-2008
Status: Terminated
Initiated: 2007-03-23
Posted: 2007-12-01
Terminated: 2011-02-11
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)