Class IIOngoingZ-1764-2025
Contec Medical Systems Co., Ltd. recalls CMS8000 Patient Monitor
Patient monitor has nine identified cybersecurity vulnerabilities.
Contec Medical Systems…May 21, 2025
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 37–48 of 49 recalls
Class IIOngoingZ-1729-2025
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot…
Remote Diagnostic Tech…May 14, 2025
Class IIOngoingZ-1666-2025
Remote Diagnostic Technologies Ltd. recalls Tempus Pro Patient Monitor
software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
Remote Diagnostic Tech…Apr 30, 2025
Class IIOngoingZ-1563-2025
Baxter Healthcare Corporation recalls Welch Allyn Welch Allyn Connex Spot Monitor
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Baxter Healthcare Corp…ILApr 23, 2025
Class IIOngoingZ-1558-2025
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Baxter Healthcare Corp…ILApr 23, 2025
Class IIOngoingZ-1110-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX550. Model Number: 866066
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1109-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX500. Model Number: 866064
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1108-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX450. Model Number: 866062
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1107-2025
Philips North America LLC recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1106-2025
Philips North America LLC recalls IntelliBridge EC10 Module. Model Number: 865115
Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
Philips North America…MAFeb 12, 2025
Class IIOngoingZ-1066-2025
Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is…
Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.
Draeger Medical System…MAFeb 5, 2025
Class IIOngoingZ-0810-2025
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring.…
Spacelabs Healthcare,…WAJan 15, 2025