Accure Laser System, Model: PFMS00004
Recall
- Recall Number
- Z-0778-2024
- Event Number
- 93696
- Firm
- Accure Acne, Inc
- FEI Number
- 3017786046
- Product Code
- GEX
- Status
- Open, Classified
- Root Cause
- Use error
- Initiated
- December 6, 2023
- Posted
- January 20, 2024
- Address
- 4699 Nautilus Ct S, Ste 205, Boulder, CO, 80301-5307
Description
Accure Laser System, Model: PFMS00004
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.
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 [email protected]
US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
22