Cl II Carestream DRX- Revolution

Company: Carestream Health Inc.
Date of Enforcement Report: 11/13/2013
Class lI:

PRODUCT

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
Recall Number Z-0179-2014

REASON
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 Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image.

RECALLING FIRM/MANUFACTURER
Carestream Health Inc., Rochester, NY on 8/29/13. Voluntary recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
190 units

DISTRIBUTION
Nationwide

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