Z-0132-2014Class II

DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/...

Name: Z-0132-2014 DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/...
Creator: Carestream Health Inc.
Published: 2013-06-19
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2013-06-19 / Terminated / root cause: design

FDA source

Carestream Health Inc. began a recall of DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to... on 2013-06-19. FDA classified it as Class II and gives the reason as "Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column". 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-0132-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Posted: 2013-11-01
Terminated: 2016-05-20
Recalling firm: Eastman Kodak Company
Product: DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
Product code: IZL System, X-Ray, Mobile
Reason for recall: Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Carestream Health Inc., sent a "URGENT: Medical Device Recall" letter dated June 17, 2013 via courier service to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that there is no opportunity for interference between the End Cover and potential obstructions as the column is descending. Carestream will deploy a field service representative to apply a warning label to the column, and to provide an addendum to the Safety and Regulatory Information manual. Your Carestream service representative will contact you to answer any questions and schedule a visit as soon as possible. If you have any questions or concerns, please contact the Carestream Customer Care Center at 1-800-328-2910 from 8am through 8pm.
Quantity in commerce: 331 units
Distribution: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, IO, KS, LA, MA, MD, MI, MN, MO, NC, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries of: Australia, Brazil, Canada, Dubai, Germany, Japan, Kuwait, Malaysia, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, and Thailand.
Product codes and lots: Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0132-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0132-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

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)