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.)
FDA Recall Z-0545-04 · Posted 2004-07-20
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Recalling FirmDatex-Ohmeda Inc
Recall StatusTerminated
Product CodeBSZ
Date Initiated2004-02-03
Date Terminated2005-11-17
Product Quantity1617 units in the United States
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed nationwide to hospitals in the Unites States.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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