Reported Sep 7, 2022 · Ongoing

Artis pheno- Model No. 10849000

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?

  • Artis pheno- Model No. 10849000
Lot codes and dates
  • UDI-DI04056869046877 Serial Numbers

    69 of 69 codes

    • 164766
    • 164140
    • 164138
    • 164287
    • 164740
    • 164210
    • 164183
    • 164184
    • 164776
    • 164312
    • 164071
    • 164034
    • 164391
    • 164763
    • 164306
    • 164735
    • 164277
    • 164095
    • 164072
    • 164771
    • 164743
    • 164048
    • 164741
    • 164241
    • 164186
    • 164069
    • 164213
    • 164728
    • 164263
    • 164060
    • 164113
    • 164398
    • 164366
    • 164279
    • 164774
    • 164074
    • 164084
    • 164086
    • 164098
    • 164153
    • 164330
    • 164389
    • 164394
    • 164772
    • 164718
    • 164163
    • 164297
    • 164778
    • 164333
    • 164377
    • 164397
    • 164300
    • 164105
    • 164227
    • 164022
    • 164250
    • 164739
    • 164703
    • 164187
    • 164211
    ***Updated 9/23/22*** 164794 164400 ***Updated 1/9/23*** 164793 164172 164795
Amount recalled
1,389 (590 US; 799 OUS) (Total)

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.

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.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 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.