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 occurred.)
Recall
- Recall Number
- Z-0545-04
- Event Number
- 28182
- Firm
- Datex-Ohmeda Inc One Ohmeda
- FEI Number
- 2183066
- Product Code
- BSZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 3, 2004
- Posted
- July 20, 2004
- Terminated
- November 17, 2005
- Address
- Dr. Box 7550, Madison, WI, 53707
Description
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 occurred.)
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.
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.
The product was distributed nationwide to hospitals in the Unites States.
1617 units in the United States