Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion
FDA device recall Z-0545-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Datex-Ohmeda Inc
- Reason for recall
- Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.
- Action taken
- Recall letters dated February 03, 2004 stated that a firm representative would contact the consignee to schedule a visit to replace software and hardware to correct the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSZ
- Quantity affected
- 1617 units in the United States
- Distribution
- The product was distributed nationwide to hospitals in the Unites States.
- Date initiated
- 2004-02-03
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-17
- Location
- Madison, WI
Monitor recalls programmatically
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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 |