Device recall

Z-0207-2020: Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision…

FDA device recall · Class II · Candela Corporation

Key facts

Recall number (Z-number) Z-0207-2020
Recall event 83839
Product Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
Product code GEX
Recalling firm Candela Corporation
Recall class Class II
Status Terminated
Termination date Oct 20, 2020
FEI number 1218402

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)