Recall Z-0778-2024
Accure Acne, Inc · initiated December 6, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Accure Laser System, Model: PFMS00004
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Use error
Action taken
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
Details
- Recall number
- Z-0778-2024
- Initiated
- December 6, 2023
- Posted by FDA
- January 20, 2024
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 22
- Distribution
- US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
- Recalling firm
- Accure Acne, Inc, Boulder, CO