Class II
Medical Device Recall: Accure Laser System, Model: PFMS00004
Accure Acne, Inc · December 6, 2023
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
States Affected
CA, CO, CT, LA, MA, MN, NJ, NY, OH, TX
Quantity Affected
22
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0778-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.