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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Recall Number Z-0050-2014
Classification Class II
Code Info 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
Product Distributed Qty 5
Reason For Recall Specific error condition could lead to unintended laser emission during laser activation.

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.