Reported Sep 26, 2018 · Terminated

ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000

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 Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Lot codes and dates
  • 164013 164011
Amount recalled
429 total

This recall covers 2 products

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

Where it was sold

  • Nationwide

Why it was recalled

Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).

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 May 17, 2019 · Data as of Sep 19, 6:16 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.