Z-2651-2017Class II

DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177...

Name: Z-2651-2017 DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177...
Creator: Carestream Health Inc
Published: 2017-05-25
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2017-05-25 / Terminated / root cause: manufacturing process

FDA source

Carestream Health Inc began a recall of DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution... on 2017-05-25. FDA classified it as Class II and gives the reason as "Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2651-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-06-19
Terminated: 2018-06-13
Recalling firm: Eastman Kodak Company
Product: DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
Product code: IZL System, X-Ray, Mobile
Reason for recall: Carestream found a single unit where four screws in the assembly were not applied in the manufacturing process. This could result in separation of the tube and yoke assembly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Carestream Health sent the URGENT MEDICAL DEVICE CORRECTION Letters and Response Forms to the US consignees on May 25, 2017, via Certified Mail, Certified Receipt Requested. Letters to foreign accounts were distributed via e-mail or courier about the same time. Customers with questions were instructed to call 1-800-328-2910.
Quantity in commerce: Domestic: 1449 units; Foreign: 1416 units
Distribution: Worldwide Distribution - US (nationwide) Internationally to Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, India, Japan, Israel, Korea, Malaysia, Maldives, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Switzerland, Taipei, Thailand, Turkey, and UAE.
Product codes and lots: Serial Numbers: Worldwide except China: 101 through 2623; China only: 800101 through 800482

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2651-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2651-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)