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Draegar Medical Systems Recalls
13 recalls on record · April 19, 2017 to May 4, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 4, 2022Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wi
Hazard: Software issue resulting in temporary loss of central monitoring functionality.
February 17, 2021Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient mo
Hazard: The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
November 20, 2019Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031,
Hazard: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
November 6, 2019Medical DevicesFDA
Draegar Medical Systems, Inc. recalls The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos.
Hazard: Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
March 13, 2019Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare P
Hazard: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
March 13, 2019Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be u
Hazard: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
May 23, 2018Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25
Hazard: Software anomaly resulting in the loss of patient settings and stored patient data.
April 25, 2018Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS2
Hazard: The invasive pressure visual and audible alarms may not activate.
March 21, 2018Medical DevicesFDA
Draegar Medical Systems, Inc. recalls INFINITY DUAL HEMO MCable Pod
Hazard: Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
July 26, 2017Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Hazard: Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.
April 19, 2017Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Hazard: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
April 19, 2017Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus
Hazard: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.
April 19, 2017Medical DevicesFDA
Draegar Medical Systems, Inc. recalls Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus.
Hazard: It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit.