Carestream DRX-Revolution Mobile X-Ray System -- Made in U — Class II medical device recall Z-0491-2014

Terminated recall by Carestream Health Inc., reported 2014-01-15, distributed nationwide. It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed

Recall number	`Z-0491-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Carestream Health Inc., Rochester, NY, United States
Recall initiated	2013-08-29
Classified	2014-01-03
Reported by FDA	2014-01-15
Terminated	2015-11-18
Distributed	Nationwide (US)
Quantity	310 systerms
Serial numbers	`111`, `114`, `119`, `121`, `122`, `123`, `125`, `126`, `134`, `142`, `143`, `151`, `152`, `153`, `154`, `155`, `161`, `162`, `163`, `164`, `165`, `166`, `167`, `168`, `169` and 285 more

Product

Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

Reason for recall

It was discovered that Carestream received a report from a customer that 2 different patients were re-exposed due to the fact that the processed images were not able to be found in the system.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0491-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.