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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 65036
Product Type Devices
Status Ongoing
Recalling Firm CEFLA DENTAL GROUP
City IMOLA, BO
State
Country IT
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
MyRay RXDC dental unit x-ray unit Model - MyRay RX DC Class II The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at maximum line current. 173 shipped to US Z-1217-2013
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