FDA Medical Device Recalls (openFDA)
Oridion Medical 1987 Ltd.: Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
- Recall number
- Z-2232-2009
- Recalling firm
- Oridion Medical 1987 Ltd.
- Product
- Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
- Status
- Terminated
- Initiated
- 2009-06-30
- Posted
- 2009-09-21
- Terminated
- 2010-10-01
- Reason
- 1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices
- Root cause
- Device Design
- Action
- Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.
- Quantity
- 326 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Software version V 3.0 and earlier. Part Number Part Description CS08651, Capnostream20 with Nellcor pulse oximetry module CS08653 Capnostream20 with Masimo pulse oximetry module CS08657 Capnostream20 with Nellcor pulse oximetry module and printer CS08659 Capnostream20 with Masimo pulse oximetry module and printer
- 510(k) numbers
- ["K060065"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 3001227743
- Firm city
- Jerusalem
- Firm state
- Har Hotzvim Industrial Park
- Firm country
- Israel
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
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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