Z-0384-2008

Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy...

Name: Z-0384-2008 Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical 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, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners... 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-0384-2008
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, 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
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: 9 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 number 1940035, Serial Numbers 3736 3756 3491 3849 3885 4087 70-4249 70-4286 70-4323

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)