FDA Medical Device Recalls (openFDA)
Accure Acne, Inc: Accure Laser System, Model: PFMS00004
- Recall number
- Z-0778-2024
- Recalling firm
- Accure Acne, Inc
- Product
- Accure Laser System, Model: PFMS00004
- Status
- Open, Classified
- Initiated
- 2023-12-06
- Posted
- 2024-01-20
- Terminated
- not on file
- 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.
- Root cause
- Use error
- Action
- On 12/6/23, "Field Safety Alert(s)" were emailed to customers informing them of the following: 1) Following these steps will minimize the likelihood of Region of Interest (ROI) misalignment: Make sure that during treatment that the handpiece tip movement is minimized and to not lift off the tip until the emission is complete and foot pedal released. Remember this order of operations to reduce the potential of misalignment: "Tip down "Pedal down "Emission completes "Pedal up "Tip up 2) Monitor the patient during treatment for unexpected levels of pain. If higher than usual stop treatment and contact the recalling firm. 3) Immediately discontinue therapy if any Skin Overtemperature alarms are observed while treating with the device in Boost mode. This could be an indication that the ROI is misaligned. Contact your Accure representative before any further use of the device. 4) Immediately discontinue therapy if any PETs are observed that are above the green range displayed on the device touchscreen. This could be an indication that the ROI is misaligned. Contact your recalling firm service representative. 5) Ask your patients to contact you immediately if they experience prolonged erythema (longer than 2 hours) or blistering. Blistering is a potential residual risk and is not expected. If it occurs, it may require medical intervention. It could also be an indication that the ROI is misaligned. 6) If ROI misalignment is suspected suspend all further use of the laser and contact the recalling firm. The firm is releasing a software upgrade to maintain the ROI in the intended monitored location regardless of movement of the handpiece tip, and will safely detect and disable the system in the event that the ROI has become misaligned. Acknowledge, and send your response to the firm, see Field Safety Notice. Customers with questions can contact the firm via email at aintintoli@accureacne.com
- Quantity
- 22
- Distribution
- US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K222109"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3017786046
- Firm city
- Boulder
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28