12 results
·
59ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
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.
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·December 23, 2020
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 for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019
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 patient's medical condition.
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·February 8, 2019
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·October 9, 2019
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·March 4, 2022
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
FDA Recall
Open, Classified
·Draegar Medical Systems, Inc.·Product code MHX·September 13, 2019
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·May 13, 2024
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code FPL·May 20, 2022
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code FMT·May 16, 2023
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023
Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·April 5, 2023
Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
FDA Recall
Open, Classified
·Draeger Medical Systems, Inc.·Product code MHX·January 14, 2025