15
Jan
2014

Carestream DRX-Revolution Mobile XRay System Cl II

0

Company: Carestream Health Inc.
Date of Enforcement Report:1/15/2014
Class lI:

PRODUCT

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.
Recall Number Z-0491-2014

REASON
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.

RECALLING FIRM/MANUFACTURER
Carestream Health Inc.,Rochester, NY on 8/29/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
310 systems

DISTRIBUTION
Nationwide.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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