Reported Sep 8, 2021 · Terminated

Artis Models with SW version VD12 listed below

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

Is this the product you have?

Artis Models with SW version VD12 listed below

7 of 7 products

Products covered by this recall
Model / numberProduct as published
10094135Artis Models with SW version VD12 listed below: Artis zee floor
10094137Artis zee ceiling
10094139Artis zee MP
10848280Artis Q floor
10848281Artis Q ceiling
10848282Q biplane
10848353Artis Q.zen floor
Lot codes and dates
  • Units
  • with SW version VD12 Serial Numbers

    70 of 70 codes

    • 104005
    • 104007
    • 104012
    • 104013
    • 105500
    • 105501
    • 109645
    • 110001
    • 110005
    • 110006
    • 110007
    • 110014
    • 110016
    • 110017
    • 110018
    • 110022
    • 110023
    • 110024
    • 110025
    • 110026
    • 110027
    • 110031
    • 110032
    • 110035
    • 110036
    • 110037
    • 110039
    • 110040
    • 110041
    • 110042
    • 110043
    • 110044
    • 110046
    • 110048
    • 110051
    • 111133
    • 111500
    • 111501
    • 111502
    • 111503
    • 111504
    • 111505
    • 111506
    • 111507
    • 111508
    • 111510
    • 122001
    • 122002
    • 122005
    • 122007
    • 123501
    • 123502
    • 139012
    • 150002
    • 150003
    • 150005
    • 150009
    • 150011
    • 159010
    • 159015
Amount recalled
70 US (172 WW)

Where it was sold

Why it was recalled

Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment

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

Want the full recall guide?

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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 10, 2023 · Data as of Sep 19, 7:00 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.