Reported Apr 15, 2020 · Terminated

ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

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?

  • ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Lot codes and dates
    • Serial Numbers 5350
    • 5410
    • 5419
    • 5481
    • 5500
    • 5488
    • 5532
    • 5540
    • 5548
    • 5572
    • 5590
    • 5601
    • 5630
    • 5640
    • 5657
    • 5699
    • 5707
    • 5737
    • 5743
    • 5748
    • 5755
    • 5784
    • 5823
    • 5843
    • 5844
    • 5851
    • 5899
    • 5833
    • 5894
    • 5830
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.

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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, 5:29 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.