Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflura
FDA device recall Z-0201-2007 · posted 2006-11-21 · Terminated
Recall details
- Recalling firm
- Datex - Ohmeda, Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAD
- Quantity affected
- 93
- Distribution
- Nationwide and Canada.
- Date initiated
- 2006-09-15
- Date posted
- 2006-11-21
- Date terminated
- 2007-05-25
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA (K000275) | Datex-Ohmeda, Inc. | 2000-04-12 |