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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Recall Number Z-0999-2013
Classification Class II
Code Info CS 2100
Product Distributed Qty 167 installed in the US
Reason For Recall There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

Event Detail

Event Id 64589
Product Type Devices
Status Ongoing
Recalling Firm Carestream Health, Inc.
City Rochester
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution