Recall Z-0545-04 ยท BSZ Gas-Machine, Anesthesia
Datex-Ohmeda Inc
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 from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurr
| Date | Jul 20, 2004 (initiated Feb 3, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1617 units in the United States |
| Distribution | The product was distributed nationwide to hospitals in the Unites States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) Datex-Engstrom, Inc., Oct 30, 1998 |