[Recalled] Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. — The canister neck bushing may become loose and separate from the body of the ca… | FDA 2019-09-10
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. |
|---|---|
| Brand / manufacturer | Candela Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0206-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 September 2019 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Candela Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.