Recall Z-1599-2013 ยท GEX Powered Laser Surgical Instrument
ConBio, a CynoSure Company
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
| Date | Jun 26, 2013 (initiated May 9, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Cynosure Inc., sent a "MEDICAL DEVICE FIELD ACTIONS NOTIFICATION" letter dated May 9, 2013 to its customers via UPS next day. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the Revlite SI Multilite Dye Handpieces upon receipt of this letter and complete and return the enclosed Field Corrective Action Acknowledgement Form via e-mail to: mflynn@cynosure.com or FAX to: 978-256-6556. A Cynosure representative will be contacting customers to schedule and arrange an exchange of the affected handpieces. If addit |
| Quantity | 12 (6 of model 659-1050; 6 of model 659-1100) |
| Distribution | Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR Hoya Photonics, Inc., Nov 19, 2010 |