Z-1432-2017Class II

PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS...

Name: Z-1432-2017 PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-01-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-01-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems... on 2017-01-25. FDA classified it as Class II and gives the reason as "Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to...". 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-1432-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Posted: 2017-03-09
Terminated: 2017-10-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens sent a Customer Safety Advisory Notice (CSAN) dated February 7, 2017, to affected customers to inform them of a planned hardware update regarding the mechanics of the overhead suspension of their Digital Linear Accelerator. The notice also explained the actions Siemens is taking to perform the necessary fix at the affected sites. Customers were advised to notify anyone at their organization that should be aware of this information. Also, the safety notice should be forwarded to the new owner and Siemens also requested they be informed of the identity of the device's new owner where possible. Customers with questions were instructed to call 1-800-888-7436. For questions regarding this recall call 610-448-6478.
Quantity in commerce: 35 systems
Distribution: Nationwide Distribution
Product codes and lots: Device Model Number 4504200 and 1940035 Serial numbers: 3009 2958 2863 2972 2646 3079 2516 2962 3055 1452 2702 2125 3066 2689 2228 2564 2507 1904 3075 2375 3013 3068 2596 3025 3049 2965 2045 3084 2855 2906 2292 2384 2067 2818 3089

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1432-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1432-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1433-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1434-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1435-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1436-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09
Z-1437-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-15	2017-03-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)