Reported Apr 15, 2020 · Terminated

MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2…

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Lot codes and dates
    • Serial Numbers 2507
    • 2516
    • 2596
    • 2689
    • 2818
    • 2962
    • 3013
    • 3103
    • 3089
    • 3136
    • 2855
    • 3296
    • 3397
    • 3591
    • 3629
    • 3639
    • 3644
    • 3702
    • 3873
    • 3939
    • 4018
    • 3986
    • 70-4146
    • 70-4347
    • 70-4363
    • 5092
    • 5114
    • 5523
    • 70-4287
    • 2045
    • 2067
    • 2125
Amount recalled
1012

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Siemens Medical Solutions USA, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 9, 2021 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.