Z-0778-2024Class II

Accure Laser System, Model: PFMS00004

Name: Z-0778-2024 Accure Laser System, Model: PFMS00004
Creator: Accure Acne, Inc
Published: 2023-12-06
License: https://open.fda.gov/license/

Accure Acne, Inc / initiated 2023-12-06 / Open, Classified

FDA source

Accure Acne, Inc began a recall of Accure Laser System, Model: PFMS00004 on 2023-12-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0778-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-06
Posted: 2024-01-20
Recalling firm: Accure Acne, Inc
Product: Accure Laser System, Model: PFMS00004
Product code: GEX Powered Laser Surgical Instrument
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 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 [email protected]
Quantity in commerce: 22
Distribution: US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0778-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0778-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-20

Product code GEX

K222109Class IIAccure LaserAccure Acne, Inc. / cleared 2022-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)