Recall Z-0126-2014— Carestream Health, Inc.

Name: FDA recall Z-0126-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-06

Class II · Terminated

Class II FDA medical device recall by Carestream Health, Inc., initiated 2013-06-06, terminated 2016-05-20. It names one FDA 510(k) clearance: K120062. Product: Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.. Reason: 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..

Recalling firm: Carestream Health, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-06
Terminated: 2016-05-20
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K120062 — DRX-REVOLUTION MOBILE X-RAY SYSTEMCarestream Health, Inc.·cleared 2012-04-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.