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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65018
Product Type Devices
Status Ongoing
Recalling Firm Chicago X-Ray Systems, Inc.
City Prospect Heights
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution- USA (nationwide) and Latin America.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. Model IntraOs 70 Class II The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h). 1960 units Z-1179-2013