Z-1138-2017Class II

Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries)...

Name: Z-1138-2017 Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries)...
Creator: Carestream Health Inc
Published: 2017-01-12
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2017-01-12 / Terminated / root cause: design

FDA source

Carestream Health Inc began a recall of Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health... on 2017-01-12. FDA classified it as Class II and gives the reason as "The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator". 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-1138-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-12
Posted: 2017-02-03
Terminated: 2018-06-13
Recalling firm: Eastman Kodak Company
Product: Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608
Product code: IZL System, X-Ray, Mobile
Reason for recall: The firm received a complaint alleging that a DRX Revolution System could not be stopped when applying the brake. The Revolution crashed into an elevator.
Root cause tag: design
FDA root cause: Device Design
Action: Carestream Health Inc. sent an URGENT: MEDICAL DEVICE CORRECTION Letter dated December 29, 2016, and response forms were sent to the US customers via Certified Mail-Return Receipt Requested on January 12, and January 13, 2017, informing them of the problem. Customers are instructed to read and complete all information and return the response form within 5 working days to the following e-mail address: [email protected], or fax the completed form to (585) 454-4493. UMDC Letters and Response Forms to Canadian Customers were sent the week of January 9, 2017, via courier. Field Safety Notice (FSN) Letters for the rest of world are in process. FSN Letters for the EMEA should be sent via courier starting later this week. US Carestream Customer Care Center #: 1-800-328-2910 (24/7). Outside of the US, please call your local Service support number.
Quantity in commerce: US: 1403 units; Foreign: 1370 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Dominican Republic, Dubai, Finland, France, Germany, Ghana, India, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Libya, Malaysia, Maldives, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates and United Kingdom.
Product codes and lots: Serial Numbers: 101 to 2545 (Worldwide except China), 800101 to 800468 (China only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-03

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)