Datex-Ohmeda S/5 Anesthesia Delivery Units
FDA device recall Z-0937-03 · posted 2003-08-28 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- Reason for recall
- Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
- Action taken
- Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 544 units
- Distribution
- The product was distributed nationwide to hospitals in the Unites States.
- Date initiated
- 2003-07-15
- Date posted
- 2003-08-28
- Date terminated
- 2005-11-08
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985) | Datex-Engstrom, Inc. | 1998-10-30 |