Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0126-2014

June 06, 2013

Class II

Product summary

Firm
Carestream Health, Inc.
Event
Event 65469
Status
Terminated
Classification
Class II
Quantity
180 units
Official record key
device-enforcement:Z-0126-2014

Official wording

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.

Code information: Serial Numbers: 111, 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, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490

Distribution pattern: Nationwide Distribution including the states of NY, TX, PA, OH, WI, CA, IL, CO, FL, IN, OK, NJ, GA, LA, AL, KS, AZ, MA, SC, MI, NC, IA, UT, VA, TN, and MN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.