FDA recall Z-0778-2024

Product

Accure Laser System, Model: PFMS00004

Reason for recall

Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.

Distribution

US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX

Key facts

Status

Ongoing

Initiation date

2023-12-06

Report date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2024