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Accure Acne, Inc recalls Accure Laser System, Model: PFMS00004
Recalled January 31, 2024 · FDA recall Z-0778-2024 · Accure Acne
Hazard
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. · FDA Class II
Units
22
Sold at
US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
Description
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.
Product
Accure Laser System, Model: PFMS00004
Manufacturer(s)
Accure Acne, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →