Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, Part Number 1406-8216-000, used with a Model 7900 Ventillator, on a
FDA device recall Z-0969-04 · 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
- Quantity affected
- 10 units
- 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATES-OHMEDA AESTIVA SMARTVENT MRI (K993410) | Datex-Ohmeda, Inc. | 2000-04-25 |