Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0179-2014 — DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients

U.S. FDA — Device Enforcement · United States · 2013-08-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0179-2014
Date of alert
2013-08-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Carestream Health Inc.
Product category
device
Product type
Devices
Reported risk: Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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