Z-0850-2008

Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part...

Name: Z-0850-2008 Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-07-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-07-27 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens... on 2007-07-27. The reason FDA records is "Door Hinge failures; loose or falling off (Stationary Structure Doors)". 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-0850-2008
Status: Terminated
Initiated: 2007-07-27
Posted: 2008-02-19
Terminated: 2011-04-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Door Hinge failures; loose or falling off (Stationary Structure Doors)
Root cause tag: design
FDA root cause: Component design/selection
Action: Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Quantity in commerce: 1,284 total for recalls Z-0850-0852-2008
Distribution: Worldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Kansas, Mississippi, Rhode Island, Washington, South Carolina, Maryland, New Hampshire, Maine, Arkansas, Idaho, Missouri, Louisiana, Oklahoma, North Dakota, Minnesota, Massachusetts, and The District of Columbia and countries of Canada and Mexico.
Product codes and lots: All Serial Numbers up to Serial Number: 3532

Product code IYE

K993425Class IIPrimusSiemens Medical Solutions USA, Inc. / cleared 1999-11-26

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)