Recall Z-0206-2020— Candela Corporation
Class II · Terminated
Class II FDA medical device recall by Candela Corporation, initiated 2019-09-10, terminated 2020-10-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.. 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.
- Recalling firm
- Candela Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-10
- Terminated
- 2020-10-20
- Firm location
- Wayland, MA, United States
Product description
Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.