Reported May 11, 2016 · Terminated

Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

Fujifilm Medical Systems U.S.A., 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: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343

Is this the product you have?

  • Smart CR Digital Computed Radiography System
  • Model NumberCR-IR346RU
Lot codes and dates
  • All serial numbers.
Amount recalled
2,062 devices

Where it was sold

  • Nationwide

Why it was recalled

Reports of failure of the device's power supply.

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 Jul 11, 2018 · Data as of Sep 19, 6:01 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.