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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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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
Distribution Pattern US (nationwide)

Product Detail

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