Z-1599-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- May 9, 2013
- Termination Date
- June 26, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 (6 of model 659-1050; 6 of model 659-1100)
Product Description
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 of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538
Reason for Recall
An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
Code Information
659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.