Reported Jan 15, 2014 · Terminated
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester,…
Carestream Health 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: Carestream Health Inc. · 150 Verona St · Rochester, NY · 14608-1733
Is this the product you have?
- Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
- Lot codes and dates
- DRX Revolution Mobile X-Ray Systems manufactured
- from June 2012 through October 2013
310 of 310 codes
Serial Numbers DRXR00690111114119121122123125126134142143151152153154155161162163164165166167168169173174176177178180181182183188189190191192196197198199201202203205206207208209211221222223224225226227
- Amount recalled
- 310 systerms domestically
Where it was sold
- Nationwide
Why it was recalled
It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.
This product could cause temporary or reversible health problems — stop using it.
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