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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 66361
Product Type Devices
Status Ongoing
Recalling Firm Convergent Dental
City Natick
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-12
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern US distribution including states of: MA, CT, NY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology. Serial Numbers: CDS1-DVSU-1B-JU-13; CDS1-7QRE-1B-JU-13; CDS1-22TZ-1B-JU-13; CDS1-PNJZ-1B-AU-13; CDS1-A4CQ-1B-AU-13 Class II Specific error condition could lead to unintended laser emission during laser activation. 5 Z-0050-2014
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