Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machin
FDA device recall Z-0967-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- Reason for recall
- Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
- Action taken
- Recall letters, dated April 26, 2004, stated that a firm representative would contact the consignee to schedule a visit to verify the proper function of each device unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBN
- Distribution
- The affected units were distributed nationwide in the United States and worldwide.
- Date initiated
- 2004-04-16
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-14
- 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 |
|---|---|---|
| OHMEDA EXCEL 3000 ANESTHESIA SYSTEM (K973896) | Ohmeda Medical | 1998-04-21 |