Accure Laser System, Model: PFMS00004

FDA device recall Z-0778-2024 · posted 2024-01-20 · Open, Classified

Recall details

Recalling firm

Accure Acne, Inc

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.

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

Root cause

Use error

Status

Open, Classified

Product code

GEX

Quantity affected

22

Distribution

US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX

Date initiated

2023-12-06

Date posted

2024-01-20

Location

Boulder, CO

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