Z-1397-2018Class II

MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035

Name: Z-1397-2018 MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-02-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-02-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for... on 2018-02-14. FDA classified it as Class II and gives the reason as "Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1397-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-14
Posted: 2018-04-17
Terminated: 2019-05-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
Root cause tag: software
FDA root cause: Software design
Action: On February 16, 2018, the recalling firm issued a Customer Advisory Notice via USPS Certified Mail to inform customers about the update of the Control Console software version 9.2.400 of the Digital Linear Accelerator to version 9.2.502. Customers were informed of the issues that would be fixed through this software update. Consignees were asked to instruct affected personnel accordingly, place the safety advisory notice in the device's instructions for use, and have personnel maintain awareness until the fix is implemented.
Quantity in commerce: 18
Distribution: Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
Product codes and lots: Serial no: 3383 5474 3296 3591 3618 3103 3986 3629 3136 70-4323 5092 3639 3274 2855 3644 4018 70-4347 3939

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1397-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1397-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1398-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1399-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1400-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1401-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1402-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

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)