Recall Z-0201-2007 ยท CAD Vaporizer, Anesthesia, Non-Heated
Datex - Ohmeda, Inc
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane.
| Date | Nov 21, 2006 (initiated Sep 15, 2006) |
| Status | Terminated |
| Reason | There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer. |
| 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 | 93 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000275 | DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA Datex-Ohmeda, Inc., Apr 12, 2000 |