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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Recall Number Z-0126-2014
Classification Class II
Code Info 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
Product Distributed Qty 180 units
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.

Event Detail

Event Id 65469
Product Type Devices
Status Ongoing
Recalling Firm Carestream Health, Inc.
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-06
Initial Firm Notification of Consignee or Public Letter
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.
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