Data Foundry

Medical device recalls 2013

Carestream DRX-Revolution Mobile X-ray System — Class II medical device recall Z-0126-2014

Terminated recall by Carestream Health, Inc., reported 2013-11-06, distributed nationwide. Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item

Recall numberZ-0126-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCarestream Health, Inc., Rochester, NY, United States
Recall initiated2013-06-06
Classified2013-10-31
Reported by FDA2013-11-06
Terminated2016-05-20
DistributedNationwide (US)
Quantity180 units
Serial numbers111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178, 180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353 and 18 more

Product

Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.

Reason for recall

Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch.

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-0126-2014. 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.