RecallRadar

FDA Device recall Z-0132-2014

DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only)

On 2013-11-13 the FDA classified a Class II recall of DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only) by Carestream Health, citing carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0132-2014
ClassificationClass II
Statusterminated
Initiated2013-06-19
Published2013-11-13
Last updated2026-09-13 11:53 UTC
CompanyCarestream Health
DistributionUS

Product

DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas

Reason

Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column.

Identifiers

code_infoSerial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0132-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.