Oridion Medical Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 08653, CS08657, and CS08659.
Brand
Oridion Medical
Lot Codes / Batch Numbers
Software version V 3.0 and earlier. Part Number Part Description CS08651
Products Sold
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
Oridion Medical is recalling Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbe due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026