Convergent Dental: Medical Device Recall in 2013 - (Recall #: Z-0050-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 12, 2013

Date Posted: October 30, 2013

Recall Number: Z-0050-2014

Event ID: 66361

Reason for Recall:

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

Status: Terminated

Product Quantity: 5

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated