Z-0177-2008

Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical

Name: Z-0177-2008 Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
Creator: Oridion Capnography Inc
Published: 2007-07-28
License: https://open.fda.gov/license/

Oridion Capnography, Inc. / initiated 2007-07-28 / Terminated / root cause: manufacturing process

FDA source

Oridion Capnography Inc began a recall of Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical on 2007-07-28. The reason FDA records is "Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0177-2008
Status: Terminated
Initiated: 2007-07-28
Posted: 2007-11-28
Terminated: 2008-09-08
Recalling firm: Oridion Capnography, Inc.
Product: Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
Product code: DQA Oximeter
Reason for recall: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
Root cause tag: manufacturing process
FDA 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 in commerce: 21
Distribution: Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
Product codes and lots: Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150 B200001135 B200001133 B200001086 B200001105 B200001104 B200001103 B200001102 B200001101 B200001325 B200001258 B200001272 B200001275 B200001289 B200001290 B200001291 B200001323

Product code DQA

K060065Class IICapnostream20 Two Parameter Bedside Monitor & Capnostream10 One Parameter Bedside MonitorOridion Capnography, Inc. / cleared 2006-05-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)