Lutronic's CLARITY II Laser System, 1,525 units distributed worldwide to US clinics and international markets, is recalled. The devices have reports of sparking and popping during use and may burn patients. Clinics and patients should stop using the device immediately and follow the manufacturer's recall instructions.
Reports of devices sparking/popping and potentially burning patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Lutronic Corporation or your healthcare provider for instructions. Notification method: E-Mail
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The CLARITY II Laser System is a medical laser device used in clinical settings for cosmetic or surgical laser procedures.
Electrical sparking or popping during operation can indicate a fault and may cause burns to patients.
This recall is not described as part of a broader industry pattern in the notice provided.
Clinics must halt use immediately. The recall involves 1,525 units distributed worldwide, creating a global safety and remediation effort for healthcare facilities.
Refer to the recall notice emailed to affected healthcare providers and the FDA recall page.
Refunds or replacements typically follow manufacturer remediation of affected units; exact timeline to be issued by Lutronic.
Keep copies of recall notices, device labels (Model No., UDI, serial numbers), and all communications with the manufacturer. Take photos of the device labels and serial numbers.
Product: CLARITY II Laser System. Model No.: 1110200210. UDI: 08809447653723. Serial numbers include: C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015, C3024K033, C3019J018, C3024K030, C3025B076, C3023K043, C3021K002, C3025E050, C3025E035, C3022L010, C3023G009, C3023J037, C3021D021. Quantity: 1,525 units. Distribution: Worldwide, including US nationwide and Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand. Sold since: Unknown. Price: Unknown.
Reports of sparking and popping during use. No injury counts are provided in the recall notice.
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