Recall Z-0778-2024 ยท GEX Powered Laser Surgical Instrument
Accure Acne, Inc
Accure Laser System, Model: PFMS00004
| Date | Jan 20, 2024 (initiated Dec 6, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Use error |
| Action | On 12/6/23, "Field Safety Alert(s)" were emailed to customers informing them of the following: 1) Following these steps will minimize the likelihood of Region of Interest (ROI) misalignment: Make sure that during treatment that the handpiece tip movement is minimized and to not lift off the tip until the emission is complete and foot pedal released. Remember this order of operations to reduce the potential of misalignment: "Tip down "Pedal down "Emission completes "Pedal up "Tip up 2) Monitor the patient during treatment for unexpected levels of pain. If higher than usual stop treatment and c |
| Quantity | 22 |
| Distribution | US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222109 | Accure Laser Accure Acne, Inc., Nov 17, 2022 |