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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description DeGotzen XRay unit XGenus Dental X-ray unit.
Recall Number Z-1020-2013
Classification Class II
Code Info 766471
Product Distributed Qty 159 units
Reason For Recall It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification

Event Detail

Event Id 64734
Product Type Devices
Status Ongoing
Recalling Firm DeGotzen
City Olgiate Olona Varese
Country IT
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US (nationwide)