Z-0126-2014Class II

Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images

Name: Z-0126-2014 Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images
Creator: Carestream Health, Inc.
Published: 2013-06-06
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-06-06 / Terminated / root cause: design

FDA source

Carestream Health, Inc. began a recall of Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images on 2013-06-06. FDA classified it as Class II and gives the reason as "Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0126-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Posted: 2013-10-31
Terminated: 2016-05-20
Recalling firm: Eastman Kodak Company
Product: Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.
Root cause tag: design
FDA root cause: Device Design
Action: On June 6, 2013 Carestream Health Inc. initiated a recall for the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health Inc. will replace the power plug in all potentially impacted DRX-Revolution Mobile X-Ray Systems. Your Carestream service representative will contact you to answer any questions and schedule a visit to replace the plug of your Mobile X-Ray System as soon as possible. If you have any questions or concerns, or if you experience any issue with your plug 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: 180 units
Distribution: Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.
Product codes and lots: Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0126-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-31

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)