Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
This recall has been terminated (originally issued September 21, 2009).
- Company
- Oridion Medical
- Recall Initiated
- June 30, 2009
- Posted
- September 21, 2009
- Terminated
- October 1, 2010
- Recall Number
- Z-2232-2009
- Quantity
- 326 units
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.