Reported May 24, 2017 · Terminated

Ziehm Imaging solo FD Mobile Fluoroscopic C-arm

Ziehm Imaging 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: Ziehm Imaging Inc · 6280 Hazeltine National Dr Ste 100 · Orlando, FL · 32822-5114

Is this the product you have?

  • Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
Lot codes and dates
    • S/N 52199
    • 52108
Amount recalled
US - 2 systems

Where it was sold

Why it was recalled

During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

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 Dec 11, 2019 · Data as of Sep 19, 4:46 PM UTC

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