FDA Medical Device Recalls (openFDA)
Oridion Capnography Inc: Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
- Recall number
- Z-0177-2008
- Recalling firm
- Oridion Capnography Inc
- Product
- Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
- Status
- Terminated
- Initiated
- 2007-07-28
- Posted
- 2007-11-28
- Terminated
- 2008-09-08
- Reason
- Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
- Root cause
- Process design
- Action
- Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007.
- Quantity
- 21
- Distribution
- Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
- Lot, serial or model codes
- Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150 B200001135 B200001133 B200001086 B200001105 B200001104 B200001103 B200001102 B200001101 B200001325 B200001258 B200001272 B200001275 B200001289 B200001290 B200001291 B200001323
- 510(k) numbers
- ["K060065"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3006678365
- Firm city
- Needham Heights
- Firm state
- MA
- 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