Reported Jan 22, 2020 · Terminated

Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for…

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 pheno, Model # 10849000. Interventional Fluoroscopic
  • X-Ray System - Product UsageAngiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients
Lot codes and dates
    • Serial Numbers 164231
    • 164234
    • 164240
    • 164241
    • 164242
    • 164244
Amount recalled
6

Where it was sold

Why it was recalled

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

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 1, 2020 · Data as of Sep 19, 5:23 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.