Reported Jul 10, 2019 · Terminated

Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135

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 floor -Interventional
  • Fluoroscopic X-Ray System Model Number10094135
Lot codes and dates
  • Serial Numbers

    63 of 63 codes

    • 135954
    • 136032
    • 136077
    • 136043
    • 136190
    • 136197
    • 136168
    • 136143
    • 136234
    • 136383
    • 136242
    • 136393
    • 136128
    • 136147
    • 136350
    • 136256
    • 136314
    • 136548
    • 136550
    • 136557
    • 136558
    • 137165
    • 137119
    • 136607
    • 137388
    • 137231
    • 137471
    • 137591
    • 137245
    • 137369
    • 137347
    • 137329
    • 137391
    • 137479
    • 137425
    • 124006
    • 138061
    • 137461
    • 137518
    • 137567
    • 137582
    • 137667
    • 137595
    • 137656
    • 138104
    • 138190
    • 124116
    • 137714
    • 124119
    • 138012
    • 138070
    • 138017
    • 138058
    • 138194
    • 138156
    • 138214
    • 138128
    • 138180
    • 138188
    • 138260
Amount recalled
63

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.

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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, 6:54 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.