Reported Jul 31, 2019 · Terminated

Artis zee biplane, Model Number 10094141

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 biplane, Model Number 10094141
Lot codes and dates
  • Serial Numbers

    268 of 268 codes

    • 153131
    • 153229
    • 153172
    • 153315
    • 153317
    • 153992
    • 153335
    • 153695
    • 153101
    • 153102
    • 153717
    • 153779
    • 153280
    • 153648
    • 153674
    • 153166
    • 153700
    • 154096
    • 153834
    • 153194
    • 153169
    • 153803
    • 153110
    • 153890
    • 154157
    • 153199
    • 153887
    • 153269
    • 154074
    • 154012
    • 153191
    • 153252
    • 153732
    • 153239
    • 154090
    • 153227
    • 153889
    • 153655
    • 153234
    • 153236
    • 153285
    • 154686
    • 153273
    • 153251
    • 153254
    • 153344
    • 154095
    • 153342
    • 154093
    • 153171
    • 153197
    • 153916
    • 153831
    • 153256
    • 153154
    • 154086
    • 153139
    • 153882
    • 153311
    • 153211
Amount recalled
268

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, 4:54 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.