Z-0050-2014 Class II Terminated
FDA device recall Z-0050-2014 was initiated by Convergent Dental on September 12, 2013 and is designated Class II. Reason for recall: Specific error condition could lead to unintended laser emission during laser activation. The recall status is terminated (terminated November 15, 2013). Affected quantity: 5.
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