FDAFDA · Food and drugs·Recall number Z-0778-2024
Accure Laser System, Model: PFMS00004
Published January 31, 2024 · Recall initiated: December 6, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Accure Acne, Inc
- Distributor
- US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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