FDA recall Z-0324-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-09-01

Report date

2023-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Needham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2024