Accure Laser System recall
Accure Laser System, Model: PFMS00004
Why was Accure Laser System recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Accure Laser System, Model: PFMS00004
- Recalling firm
- Accure Acne, Inc
- Quantity
- 22
- Distribution
- US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)