Accure Acne, Inc. is recalling 22 units of the Accure Laser System (Model PFMS00004) because the device's spot tracking system can become misaligned. This defect can cause the laser to deliver higher-than-expected energy to the skin, which may result in painful blistering for patients undergoing treatment. These professional medical devices were distributed to clinics in 10 states, including California, Colorado, New York, and Texas.
The misaligned tracking system causes laser energy to be focused incorrectly on epidermal tissue rather than the intended target, leading to unintended skin damage and the formation of blisters.
Manufacturer Notification and Correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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