Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk
Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of electrical shock, which is a risk-of-harm product hazard where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria.
Plain-English summary
Cynosure, Inc. is recalling 322 units of the Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System. The recall covers all serial numbers of the affected handpieces.
The recall was initiated because there is a potential risk of electrical shock if the laser system is turned on and the user adjusts, installs, or removes the XPL pulsed light handpiece. This hazard is associated with the specific interaction between the powered system and the handpiece during maintenance or setup.
The affected products were distributed worldwide, including in the United States, Australia, Canada, France, Germany, Italy, the Netherlands, Ukraine, and the United Kingdom. Users of the Cynosure Elite MPX Laser System should stop using the Elite XPL handpiece and contact Cynosure, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
- Manufacturer
- Cynosure, Inc.
- Hazard
- Affected units
- 322
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial numbers
Distribution
Distributed nationwide across the United States.
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