Reported Jul 31, 2019 · Terminated

Artis zee ceiling, Model Number 10094137

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 ceiling, Model Number 10094137
Lot codes and dates
  • Serial Numbers

    428 of 428 codes

    • 146669
    • 146877
    • 146996
    • 146663
    • 147100
    • 146286
    • 146292
    • 146410
    • 146676
    • 147155
    • 147049
    • 147233
    • 146406
    • 146407
    • 146411
    • 146121
    • 146710
    • 146945
    • 147084
    • 147189
    • 147190
    • 146679
    • 146766
    • 146232
    • 146408
    • 146409
    • 146728
    • 146335
    • 146659
    • 146993
    • 146898
    • 146965
    • 146221
    • 147273
    • 146814
    • 146871
    • 146952
    • 147030
    • 147239
    • 146988
    • 146899
    • 146368
    • 146643
    • 146650
    • 146980
    • 146361
    • 146365
    • 146366
    • 146369
    • 146912
    • 147036
    • 146116
    • 146164
    • 146168
    • 147079
    • 147371
    • 146156
    • 146342
    • 146343
    • 147129
Amount recalled
428

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, 5:35 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.