Reported Jul 31, 2019 · Terminated

AXIOM Artis dFC, Model Number 7412807

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?

  • AXIOM Artis dFC, Model Number 7412807
Lot codes and dates
  • Serial Numbers

    148 of 148 codes

    • 37701
    • 35374
    • 35937
    • 35456
    • 35327
    • 35368
    • 35432
    • 35690
    • 35301
    • 35451
    • 35553
    • 35427
    • 35743
    • 35750
    • 35762
    • 35778
    • 35788
    • 35764
    • 35736
    • 35350
    • 35369
    • 35601
    • 35664
    • 35730
    • 35783
    • 35376
    • 35714
    • 35547
    • 35325
    • 35314
    • 35522
    • 35635
    • 35660
    • 35333
    • 35511
    • 35536
    • 35560
    • 35329
    • 35655
    • 35810
    • 35335
    • 35353
    • 35359
    • 35410
    • 35599
    • 35556
    • 35361
    • 35283
    • 35828
    • 35380
    • 35893
    • 35351
    • 35815
    • 35306
    • 35390
    • 35525
    • 35921
    • 35727
    • 35441
    • 35465
Amount recalled
148

This recall covers 23 products

The agency filed one notice per product. You are reading one of them; the other 22 are below.

10 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

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 Sep 18, 2020 · Data as of Sep 19, 7:33 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.