FDA Medical Device Recalls (openFDA)
Datex-Ohmeda: Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
- Recall number
- Z-0611-03
- Recalling firm
- Datex-Ohmeda
- Product
- Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option
- Status
- Terminated
- Initiated
- 2002-09-16
- Posted
- 2003-03-05
- Terminated
- 2004-07-02
- Reason
- Falsely high blood oxygen saturation readings in some circumstances which could result in no alarm in a critical life-threatening situation.
- Root cause
- Other
- Action
- 'Medical Device Advisory Notice' letters dated September 16, 2002 were sent to the consignees, gave recommendations about alternative monitoring for certain patients, and stated that there would be a field correction to reduce the possibility of the problem.
- Quantity
- 85
- Distribution
- Nationwide in the United States and worldwide.
- Lot, serial or model codes
- All units with N-XOSAT SpO2 measurement option distributed prior to the recall. September 16, 2002
- 510(k) numbers
- ["K012837"]
- PMA numbers
- not on file
- Product code
- DPZ
- 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