Z-0800-2015Class II

DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and...

Name: Z-0800-2015 DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and...
Creator: Carestream Health Inc
Published: 2014-11-25
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2014-11-25 / Terminated / root cause: design

FDA source

Carestream Health Inc began a recall of DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health... on 2014-11-25. FDA classified it as Class II and gives the reason as "While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that...". 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-0800-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-25
Posted: 2014-12-16
Terminated: 2016-06-06
Recalling firm: Eastman Kodak Company
Product: DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray generator, image receptor, imaging display and software for acquiring medical diagnostic images outside of a standard x-ray room. The DRX-Revolution Mobile X-Ray System has a motor for driving the system so that the operator does not have to push the system, but can walk behind the system while it is moving from one location to another.
Product code: IZL System, X-Ray, Mobile
Reason for recall: While servicing a unit at a customer site, a field engineer discovered a broken bolt from the carriage assembly. Carestream has identified an issue related to the DRX-Revolution Mobile X-Ray System in which bolts that secure the x-ray tube assembly/boom to the device mounting block may break. It has been determined that this issue is a result of an improperly assembled part which holds the x-ray
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Carestream, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 11/20/2014 to US Consignees/customers via Certified Mail on 11/25/2014. Foreign accounts will be notified as soon as possible. The letter described the product, problem and actions to taken. The customers were instructed if they observe a loosened boom to follow the procedure for turning the system off; stop using the device and contact Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis; Outside of the U.S., call your local Service support number. Carestream Health Service representative will contact all customers to schedule a visit to inspect the DRX-Revolution Mobile X-Ray System. If a repair is required it will be completed by a Carestream Field Engineer. If you have any questions, contact the Regulatory Affairs Manager at 585-627-8230 or Carestream Customer Care Center in the U.S. at 1-800-328-2910, available 7 days per week on a 24 hour basis.
Quantity in commerce: 629 units (Domestic: 358 units; Foreign: 271 units)
Distribution: Worldwide Distribution: US (nationwide) and countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, ITALY, JAPAN, KOREA, KUWAIT, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, and UNITED KINGDOM.
Product codes and lots: Serial Numbers 101 to 764

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0800-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0800-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12

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)