Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General De
FDA device recall Z-1599-2013 · posted 2013-06-26 · Terminated
Recall details
- Recalling firm
- ConBio, a CynoSure Company
- 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.
- Action taken
- 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 additional information is required please contact VP of Regulatory Affairs and Quality Systems at 978-367-2350 or via email at ikulinets@cynosure.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2013-05-09
- Date posted
- 2013-06-26
- Date terminated
- 2013-06-26
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR (K103118) | Hoya Photonics, Inc. | 2010-11-19 |