Device product
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Z-0050-2014
Product summary
- Event
- Event 66361
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5
- Official record key
device-enforcement:Z-0050-2014
Official wording
Reason: Specific error condition could lead to unintended laser emission during laser activation.
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.
Derived failure modes
-
Unknown
Specific error condition could lead to unintended laser emission during laser activation.