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DATEX--OHMEDA, INC.

DATEX--OHMEDA, INC. Recalls

All product recalls associated with DATEX--OHMEDA, INC..

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Recall Summary

Total Recalls

47

Past Year

0

Class I (Serious)

0

Most Recent

Sep 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 47 recalls

Giraffe OmniBed (GE Healthcare) – Door Screw Loose (2024)

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.

FDASep 3, 2024Nationwide• DATEX--OHMEDA, INC.

Giraffe OmniBed (GE Healthcare) – Door Screw Loose (2024)

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.

FDASep 3, 2024Nationwide• DATEX--OHMEDA, INC.

Amingo (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

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FDA

Jul 12, 2024

Nationwide

• Datex-Ohmeda, Inc.

Aisys CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

ACGO Conversion Kit (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aisys CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Avance CS2 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aespire 100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aespire 7900 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aespire 7100 (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aisys (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Avance (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Aespire View (Datex-Ohmeda) – Gas Outlet Risk (2024)

Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

FDAJul 12, 2024Nationwide• Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc.: EVair air compressor, model numbers: M1230849 and M1230847

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 Engstrm 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.

FDADec 29, 2023Nationwide• Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc.: EVair 03 (Jun-air) air compressor, model numbers: 160900...

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 Engstrm 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.

FDADec 29, 2023Nationwide• Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc.: EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ,...

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 Engstrm 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.

FDADec 29, 2023Nationwide• Datex-Ohmeda, Inc.

DATEX--OHMEDA, INC.: GE Healthcare Giraffe Incubator Carestation CS1, Infant I...

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.

FDAJun 6, 2023Nationwide• DATEX--OHMEDA, INC.

DATEX--OHMEDA, INC.: GE Healthcare Giraffe Omnibed Carestation CS1, combinatio...

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.

FDAJun 6, 2023Nationwide• DATEX--OHMEDA, INC.

DATEX--OHMEDA, INC.: Giraffe OmniBed, with the following Model Numbers: 6650-0...

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

FDAMay 19, 2023Nationwide• DATEX--OHMEDA, INC.

DATEX--OHMEDA, INC.: Giraffe OmniBed Carestation CS1, Model Numbers: a. 208...

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

FDAMay 19, 2023Nationwide• DATEX--OHMEDA, INC.