Datex-Ohmeda Recalls
26 recalls on record · June 27, 2018 to June 24, 2026 · Medical Devices
Recalls by year
18
23
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
Datex-Ohmeda Inc recalls Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M109
Hazard: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
June 24, 2026Medical DevicesFDA
Datex-Ohmeda Inc recalls Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro
Hazard: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
June 24, 2026Medical DevicesFDA
Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826
Hazard: Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
November 6, 2024Medical DevicesFDA
DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 20828
Hazard: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
November 6, 2024Medical DevicesFDA
DATEX--OHMEDA, INC. recalls GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 208
Hazard: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Amingo. OUS only.
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 23, 2024Medical DevicesFDA
DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Hazard: GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
October 23, 2024Medical DevicesFDA
DATEX--OHMEDA, INC. recalls GE Heathcare Giraffe OmniBed; neo natal incubator
Hazard: GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
February 7, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model
Hazard: GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
February 7, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Hazard: GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
February 7, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls EVair air compressor, model numbers: M1230849 and M1230847
Hazard: GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
July 12, 2023Medical DevicesFDA
DATEX--OHMEDA, INC. recalls Beside panel FRU (Field Replacement Units) Kits
Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
July 12, 2023Medical DevicesFDA
DATEX--OHMEDA, INC. recalls Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094
Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
July 12, 2023Medical DevicesFDA
DATEX--OHMEDA, INC. recalls Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M113582
Hazard: GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices
August 15, 2018Medical DevicesFDA
Datex-Ohmeda, Inc. recalls The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neona
Hazard: The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
June 27, 2018Medical DevicesFDA
Datex-Ohmeda, Inc. recalls CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to
Hazard: Potential for the display processor to experience an unexpected failure.