Reported Jul 10, 2019 · Terminated

Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

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 zeego--Interventional
  • Fluoroscopic X-Ray System Model Number10280959
Lot codes and dates
  • Serial Numbers
    • 160335
    • 160430
    • 160368
    • 160469
    • 160357
    • 160370
    • 160369
    • 160509
    • 160427
    • 160433
    • 160443
    • 160428
    • 160429
    • 160463
    • 160001
    • 160461
    • 160486
    • 160800
    • 160487
    • 160488
    • 160507
    • 160840
    • 160862
    • 160856
    • 160823
    • 160914
    • 160930
    • 161235
    • 160401
Amount recalled
29

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.

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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, 5:33 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.