Manufacturer

Draegar Medical Systems, Inc.

13 recalls in our database name Draegar Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 13
Critical: 0
Severe: 1
Most recent: 2022-05-04

Of the 13 recalls from Draegar Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

HighFDA (Devices)·Z-1012-2022·2022-05-04
Drager Infinity CentralStation Software Temporary Monitoring Functionality Loss
Drager is recalling Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12 due to a temporary loss of central monitoring functionality. The software is used for patient monitoring with wireless telemetry devices.
Product
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1104-2021·2021-02-17
Draegar Infinity Acute Care System Recall for Random Reboot Defect
Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.
Product
Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2020·2019-11-20
Draeger Infinity M300 Telemetry Devices Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling Infinity M300 telemetry monitoring devices due to cybersecurity vulnerabilities including DDoS, Spoofing, and Tampering.
Product
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0258-2020·2019-11-06
Draeger Infinity Acute Care System Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling 5,634 Infinity Acute Care System monitors due to cybersecurity vulnerabilities that may cause device reboots and loss of alarm functionality.
Product
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2019·2019-03-13
Draegar Medical Systems Recalls Omega Patient Monitor Software
Draegar Medical Systems is recalling Omega patient monitor software due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.
Product
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2019·2019-03-13
Draeger Infinity Delta Patient Monitors Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling Infinity Delta patient monitors due to cybersecurity vulnerabilities that may cause device reboots or loss of functionality.
Product
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2018·2018-05-23
Draeger Infinity Acute Care System Recalled for Software Anomaly
Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.
Product
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1382-2018·2018-04-25
Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling Infinity Acute Care System monitoring solutions because invasive pressure alarms may not activate.
Product
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2018·2018-03-21
Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk
Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.
Product
INFINITY DUAL HEMO MCable Pod
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2734-2017·2017-07-26
Draeger Infinity Acute Care System Recall for Alarm Failure
Draeger Medical Systems is recalling Infinity Acute Care Systems (M540) because specific units may fail to display audio or visual alarms.
Product
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-1773-2017·2017-04-19
Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure
Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.
Product
Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1774-2017·2017-04-19
Draegar Medical Systems Recalls Kappa and Scio Patient Monitors
Draegar Medical Systems is recalling Kappa and Scio patient monitors because a low oxygen alarm may fail to sound when oxygen levels drop below the set limit.
Product
Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthca
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2017·2017-04-19
Draeger Medical Systems Recalls Delta Patient Monitors Due to Low Oxygen Alarm Failure
Draeger Medical Systems is recalling Delta patient monitors used with Scio gas modules because the low oxygen alarm may fail to sound when oxygen levels drop below the set limit.
Product
Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, a
Category
Medical Device
Distribution
Distributed nationwide