Device recall

Z-0859-06: Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative…

FDA device recall · Class II · Covidien LP

Key facts

Recall number (Z-number) Z-0859-06
Recall event 35283
Product Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue.
Product code GEI
Recalling firm Covidien LP
Recall class Class II
Status Terminated
Termination date Feb 26, 2009
510(k) numbers K984552
FEI number 1717344

At a glance

  • 1–9 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)