Reported Jul 10, 2019 · Terminated

Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System 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?

  • Siemens Artis zee biplane-Interventional
  • Fluoroscopic X-Ray System Model Number10094141
Lot codes and dates
  • Serial Numbers

    120 of 120 codes

    • 153883
    • 154041
    • 153640
    • 153772
    • 154007
    • 153870
    • 153762
    • 153700
    • 153797
    • 153827
    • 153898
    • 153779
    • 153869
    • 153952
    • 153736
    • 153829
    • 153763
    • 153998
    • 153819
    • 153758
    • 153928
    • 153760
    • 153865
    • 153903
    • 153908
    • 154592
    • 153863
    • 154785
    • 154079
    • 153988
    • 153882
    • 153831
    • 153939
    • 153875
    • 153847
    • 153930
    • 153913
    • 153890
    • 153922
    • 153992
    • 153916
    • 153975
    • 154012
    • 153947
    • 154076
    • 154086
    • 154058
    • 154028
    • 154073
    • 154048
    • 154034
    • 153987
    • 154093
    • 154090
    • 154074
    • 154052
    • 154075
    • 154406
    • 154408
    • 154459
Amount recalled
120

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

7 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Siemens Medical Solutions USA, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 9, 2021 · Data as of Sep 19, 6:52 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.