ConBio Recalls Multilite Dye Handpieces for Display Identification Inconsistency
ConBio is recalling 12 Multilite Dye Handpieces for the RevLite SI Laser due to an electronic display inconsistency that may confuse users.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a display inconsistency that may confuse users, which is a minor labeling/identification error without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
ConBio, a CynoSure Company, is recalling 12 Multilite Dye Handpieces, which are optional accessories for the RevLite SI Laser system. The RevLite SI Laser is intended for general dermatology, dermatologic, and general surgical procedures, including tattoo removal, pigmented lesion removal, and skin resurfacing.
The recall was initiated because an inconsistency was identified related to the electronic display identification of the handpieces. This issue may confuse users. The affected units include six of model 659-1050 (585 nm) and six of model 659-1100 (650 nm).
The handpieces were distributed worldwide, including nationwide in the United States (specifically Illinois, Maine, New Mexico, and Virginia) and in Australia and Chile. Users should contact ConBio for further instructions regarding the recall.
The recalled product
- Product
- Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening…
- Manufacturer
- ConBio, a CynoSure Company
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)
- 659-1050-585 nm Handpiece
Distribution
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