FDA Medical Device Recalls (openFDA)
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 occurred.)
- Recall number
- Z-0545-04
- Recalling firm
- Datex-Ohmeda Inc
- 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.)
- Status
- Terminated
- Initiated
- 2004-02-03
- Posted
- 2004-07-20
- Terminated
- 2005-11-17
- 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.
- Lot, serial or model codes
- The affected units in the United States have serial numbers between 40013635 and 40162379.
- 510(k) numbers
- ["K973985"]
- PMA numbers
- not on file
- Product code
- BSZ
- Firm FEI
- 2183066
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28