FDA Device recall Z-0778-2024
Accure Laser System, Model: PFMS00004
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Accure Laser System, Model: PFMS00004 by Accure Acne, citing 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 blis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0778-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-06 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accure Acne |
| Distribution | CA, CO, CT, LA, MA, MN, NJ, NY, OH, TX |
Product
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.
Identifiers
| code_info | UDI-DI: 08059173392230, Serial Numbers: LAD0000-0004, LAD0000-0014, PROT01-0720, LAD0000-0012, LAD0000-0005, LAD2216-0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0778-2024%22
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