FDA Enforcement
Class II
Ongoing
Accure Laser System, Model: PFMS00004
Recall: Z-0778-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0778-2024
- Event ID
- 93696
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Accure Acne, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- December 6, 2023
- Classification Date
- January 20, 2024
- Address
- 4699 Nautilus Ct S Ste 205, N/A, Boulder, CO, 80301-5307, United States
Description
Accure Laser System, Model: PFMS00004
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.
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
Distribution
US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
Quantity
22