Accure Acne, Inc: Accure Laser System, Model: PFMS00004

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.

Details from the source

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 Quantity: 22 Lot/code info: UDI-DI: 08059173392230, Serial Numbers: LAD0000-0004, LAD0000-0014, PROT01-0720, LAD0000-0012, LAD0000-0005, LAD2216-0623, LAD2356-0723, LAD0000-0003, PROTO07-1120, LAD2076-0623, LAD0000-0011, LAD0000-0008, LAD0000-0010, LAD2357-0723, LAD2075-0623, LAD2232-0723, LAD0000-0013, LAD0000-0009, LAD0000-0006, LAD0000-0001, PROT06-1120, LAD2507-0723

UPC codes

08059173392230

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.