Z-0545-04

Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The...

Name: Z-0545-04 Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The...
Creator: Datex-Ohmeda Inc
Published: 2004-02-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2004-02-03 / Terminated

FDA source

Datex-Ohmeda Inc began a recall of 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... on 2004-02-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0545-04
Status: Terminated
Initiated: 2004-02-03
Posted: 2004-07-20
Terminated: 2005-11-17
Recalling firm: GE Healthcare
Product: 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.)
Product code: BSZ Gas-Machine, Anesthesia
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.
FDA 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 in commerce: 1617 units in the United States
Distribution: The product was distributed nationwide to hospitals in the Unites States.
Product codes and lots: The affected units in the United States have serial numbers between 40013635 and 40162379.

Product code BSZ

K973985Class IIAs/3 Anaesthesia Delivery Unit (As/3 Adu)Datex-Engstrom, Inc. / cleared 1998-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)