Reported Jul 31, 2019 · Terminated

AXIOM Artis dBA, Model Number 7555357

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 dBA, Model Number 7555357
Lot codes and dates
  • Serial Numbers

    85 of 85 codes

    • 53181
    • 53023
    • 53167
    • 53104
    • 53067
    • 53093
    • 53162
    • 53706
    • 53058
    • 53098
    • 53253
    • 53016
    • 53188
    • 53209
    • 53223
    • 53700
    • 53017
    • 53114
    • 53063
    • 53219
    • 53033
    • 53142
    • 53116
    • 53002
    • 53086
    • 53195
    • 53165
    • 53076
    • 53064
    • 53124
    • 53176
    • 53078
    • 53111
    • 53227
    • 53202
    • 53133
    • 53140
    • 53047
    • 53710
    • 53190
    • 53180
    • 53128
    • 53185
    • 53170
    • 53187
    • 53019
    • 53141
    • 53084
    • 53074
    • 53225
    • 53215
    • 53189
    • 53056
    • 53166
    • 53149
    • 53020
    • 53096
    • 53009
    • 53147
    • 53070
Amount recalled
85

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, 6:17 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.