Z-0179-2014Class II

DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150...

Name: Z-0179-2014 DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150...
Creator: Carestream Health Inc.
Published: 2013-08-29
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-08-29 / Terminated / root cause: software

FDA source

Carestream Health Inc. began a recall of DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform... on 2013-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0179-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Posted: 2013-11-07
Terminated: 2016-06-28
Recalling firm: Eastman Kodak Company
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
Product code: IZL System, X-Ray, Mobile
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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 190 units
Distribution: 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.
Product codes and lots: Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0179-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0179-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07
Z-0180-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07

Product code IZL

K120062Class IIDrx-Revolution Mobile X-Ray SystemCarestream Health, Inc. / cleared 2012-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)