Accure Laser System recalled due to spot tracking misalignment risk
Accure Acne, Inc. is recalling the Accure Laser System Model PFMS00004 because its spot tracking system may misalign, potentially delivering higher-than-expected laser energy that could cause blistering.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with no reported injuries or hospitalizations. The hazard is a risk-of-harm situation where potential laser burn/blistering injury has not yet been reported, meeting the criteria for a High severity rating.
Plain-English summary
Accure Acne, Inc. is recalling 22 Accure Laser System devices, Model PFMS00004, distributed across the United States.
The recalled laser systems have a spot tracking system that may become misaligned. If misalignment occurs, the system may deliver higher-than-expected levels of laser energy to the skin's outer layer (epidermis), creating a risk of blistering.
The affected devices were distributed to facilities in Colorado, California, Connecticut, New York, New Jersey, Minnesota, Louisiana, Ohio, Massachusetts, and Texas. Patients or healthcare providers who have used or currently use this device should be aware of this potential hazard.
If you own or operate one of the recalled devices, contact Accure Acne, Inc. for further instructions. Do not use the device until you have received guidance from the manufacturer.
The recalled product
- Product
- Accure Laser System, Model: PFMS00004
- Manufacturer
- Accure Acne, Inc
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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