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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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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.

Product Detail

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