Home / Recalls / Convergent Dental / Z-0050-2014

Z-0050-2014 Class II Terminated

Recalled by Convergent Dental — Natick, MA

Recall Details

Product Type: Devices
Report Date: October 30, 2013
Initiation Date: September 12, 2013
Termination Date: November 15, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5

Product Description

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

Reason for Recall

Specific error condition could lead to unintended laser emission during laser activation.

Distribution Pattern

US distribution including states of: MA, CT, NY.

Code Information

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