Reported Jul 31, 2019 · Terminated

AXIOM Artis MP, Model Number 5904466

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 MP, Model Number 5904466
Lot codes and dates
  • Serial Numbers
    • 20334
    • 20052
    • 20303
    • 20238
    • 20242
    • 20322
    • 20282
    • 20363
    • 20338
    • 20295
    • 20348
    • 20172
    • 20264
    • 20367
    • 20258
    • 20265
    • 20250
    • 20249
    • 20281
    • 20243
    • 20339
    • 20321
    • 20294
    • 20254
Amount recalled
24

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, 4:46 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.