Z-0783-2012

Mevatron 77; Siemens Healthcare Concord, CA 94520

Name: Z-0783-2012 Mevatron 77; Siemens Healthcare Concord, CA 94520
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-12-01
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-12-01 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron... on 2011-12-01. The reason FDA records is "Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0783-2012
Status: Terminated
Initiated: 2011-12-01
Posted: 2012-01-17
Terminated: 2013-12-02
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Mevatron 77; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters.
Quantity in commerce: 327 Active Devices - all models
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: Part number 5659503, all units

Product code IYE

K882729Class IIMevatron, M 2 ClassSiemens Medical Laboratories, Inc. / cleared 1988-09-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)