Z-2232-2009

Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS...

Name: Z-2232-2009 Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS...
Creator: Oridion Medical 1987 Ltd.
Published: 2009-06-30
License: https://open.fda.gov/license/

Oridion Medical 1987 Ltd. / initiated 2009-06-30 / Terminated / root cause: design

FDA source

Oridion Medical 1987 Ltd. began a recall of Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659 on 2009-06-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2232-2009
Status: Terminated
Initiated: 2009-06-30
Posted: 2009-09-21
Terminated: 2010-10-01
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.
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: 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 tag: design
FDA 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 in commerce: 326 units
Distribution: Nationwide.
Product codes and lots: 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

Product code CCK

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)