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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description 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
Classification Class II
Code Info Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware
Product Distributed Qty 190 units
Reason For Recall 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.

Event Detail

Event Id 66067
Product Type Devices
Status Ongoing
Recalling Firm Carestream Health Inc.
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution:AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MI, MO, NE, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, and WV.