Z-0324-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 units
Product Description
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
Reason for Recall
It has been found that potential unintended laser activation can occur without foot pedal depression.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.
Code Information
Solea Model 3.0: UDI-DI: 00850634007018; Serial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401