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Terminated

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

FDA Recall Z-0179-2014 · Posted 2013-11-07

Recalling FirmCarestream Health Inc.
Recall StatusTerminated
Product CodeIZL
Date Initiated2013-08-29
Date Terminated2016-06-28
Product Quantity190 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

Firm Action

The firm, Carestream Health Inc., sent an "Urgent: Medical Device Recall" letter dated August 29, 2013 to its customers. The letter described the product, problem and actions taken. Carestream has developed a software patch that will allow Normal Exposure Mode and Extended Exposure Mode images to be taken in any order and will install the patch in all DRX-Revolution, DRC-Mobile and DRX-Transportable Systems with software version 5.5 or higher and Detector firmware version 69 or higher. No DRX Transportables were affected. Your Carestream service representative will install the patch at your next service call. If you have questions or concerns, or if you experience an issue prior to our visit, please contact the Carestream Customer Care Center at 1-800-328-2910, 8am through 8pm Eastern Standard Time.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120062DRX-REVOLUTION MOBILE X-RAY SYSTEMCarestream Health, Inc. · 2012-04-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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