Recall Z-0208-2020 ยท GEX Powered Laser Surgical Instrument
Candela Corporation
Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
| Date | Oct 24, 2019 (initiated Sep 10, 2019) |
| Status | Terminated |
| Reason | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules |
| Root cause | Other |
| Action | 1. Immediately examine your inventory and quarantine the identified lots of the GentleCool Pro Cryogen Canister. 2. Immediately discontinue use and distribution of the identified lots of the GentleCool Pro Cryogen Canister. 3. Please complete and return the enclosed Acknowledgement Form - GentleCool Pro Canister Recall. The completed form must be scanned and emailed to cryogen.usa@candelamedical.com within 24 hours. 4. If you may have further distributed this product, please identify those locations and notify them at once of this product recall. Your communication should include a copy of |
| Quantity | in total 7,560 canisters (3240 additional as of 2/5/20) |
| Distribution | States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa Vietnam Hong Kong Japan New Zealand Australia China Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.