FDA (Devices) recall action 80895
The FDA (Devices) publishes a recall like this one as 37 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 37 pages.
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Oridion Medical is recalling 56 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 3,143 CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 144 CAPNOSTREAM 20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 2,806 Capnostream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 245 CapnoStream 20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 22 refurbished Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling five refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 11 refurbished Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling three Capnostream20 M bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 16 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 46 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling five Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 23 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling six refurbished Capnostream20 patient monitors because alarm and time settings may reset to factory defaults when powered off.
Oridion Medical is recalling CAPNOSTREAM 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 264 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 696 Capnostream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 262 Capnostream20 M NICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 769 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling five Capnostream20 M Adult ICU monitors because date, time, and alarm settings may reset to factory defaults when powered off.
Oridion Medical is recalling 192 CapnoStream 20P patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.