Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0201-2007

Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic...

GE Healthcare / initiated 2006-09-15 / Terminated

Datex - Ohmeda, Inc began a recall of Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane on . The reason FDA records is "There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0201-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.
Product code
CAD Vaporizer, Anesthesia, Non-Heated
Reason for recall
There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
FDA root cause
Other
Action
An Urgent Medical Device Correction letter dated September 15, 2006, was sent to affected customers. The letter describes the issue, states that a GE representative will contact affected accounts to arrange for the vaporizer exchange at no charge.
Quantity in commerce
93
Distribution
Nationwide and Canada.
Product codes and lots
serial numbers: AETK25021 thru AETK25023, AETK25024, AETK25025, AETK25027 thru AETK25030, AETK27001, AETK27002, AETK27004, AETK27006, AETK27007, AETK27010 thru AETK27015, AETK27017, AETK27019, AETK27020, AETK27024, AETK27025, AETK27027, AETK27031 thru AETK27034, AETK27039, AETK27040, AETK28001 thru AETK28003, AETK28005, AETK28006, AETK28008, AETK28010, AETK28011, AETK28013 thru AETK28017, AETK28019, AETK28021, AETK28023 thru AETK28025, AETK28029, AETK28031thru AETK28038, AETK28040 thru AETK28046, AETK28048, AETK28050 thru AETK28052, AETK28056, AETK28057, AETK28059, AETK28063, AETK28065, AETK28067, AETK28070 thru AETK28072, AETK28074 thru AETK28076, AETK29004, AETK29006, AETK29035, AETK29037, AETK29039, AETK29043, AETK29045, AETK29061, AETK29068, AETK29073, AEWK30001.