Reported Jul 31, 2019 · Terminated

AXIOM Artis dFA, Model Number 7555373

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 dFA, Model Number 7555373
Lot codes and dates
  • Serial Numbers
    • 50063
    • 50059
    • 50006
    • 50064
    • 50189
    • 50044
    • 50074
    • 50101
    • 51719
    • 50062
    • 50065
    • 50087
    • 50167
    • 50039
    • 50084
    • 51706
    • 51707
    • 50048
    • 50161
    • 50093
    • 50206
    • 50057
    • 50081
    • 50133
    • 50040
    • 50016
    • 50120
    • 50191
    • 51701
    • 50027
    • 51700
    • 50139
    • 50004
    • 50010
    • 50024
    • 50142
    • 50079
    • 50132
    • 50050
Amount recalled
39

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, 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.