FDA Medical Device Recalls (openFDA)
Datex-Ohmeda Inc: Datex-Ohmeda Cardiocap/5 Patient Monitors
- Recall number
- Z-0143-04
- Recalling firm
- Datex-Ohmeda Inc
- Product
- Datex-Ohmeda Cardiocap/5 Patient Monitors
- Status
- Terminated
- Initiated
- 2003-10-17
- Posted
- 2004-07-20
- Terminated
- 2005-11-15
- Reason
- Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
- Root cause
- Other
- Action
- Recall letters dated October 15, 2003 were sent to the consignees on 10/17/03. The letters request that the consignees order service kits to correct the units and use the kits to make the corrections of the devices.
- Quantity
- 875 units
- Distribution
- The monitors were shipped to consignees located nationwide in the United States and to foreign consignees located worldwide.
- Lot, serial or model codes
- The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product. The consignees notified of the field correction had purchased both the monitors and the stands.
- 510(k) numbers
- ["K992323","K012837"]
- PMA numbers
- not on file
- Product code
- MHX
- 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