Reported Dec 1, 2021 · Terminated

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and…

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 zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and
  • interventional procedure Model Number10094139
Lot codes and dates
  • Serial Numbers
    • 159030
    • 159034
    • 159038
    • 159032
    • 159046
    • 159054
    • 159015
    • 159058
    • 159028
    • 159037
    • 159026
    • 159042
    • 159047
    • 159025
    • 159024
    • 159021
    • 159041
    • 159049
    • 159010
  • Expanded Recall 11/15/21159065
Amount recalled
19 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in 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 Jun 18, 2024 · Data as of Sep 19, 7:37 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.