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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

Past Year

Class I (Serious)

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 21–40 of 47 recalls

DATEX--OHMEDA, INC.: Beside panel FRU (Field Replacement Units) Kits

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: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Ele...

The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.

FDAAug 28, 2008AL, AK, CA +27 more• Datex - Ohmeda, Inc

Datex Ohmeda, Inc. dba GE Healthcare: Giraffe OmniBed, labeled in part: ***GE Healthcare 8880...

Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.

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FDA

Jun 20, 2008

Nationwide

• Datex Ohmeda, Inc. dba GE Healthcare

Datex Ohmeda, Inc. dba GE Healthcare: Panda iRes and Giraffe Infant Warmers, labeled in part***...

Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety.

FDAMay 20, 2008Nationwide• Datex Ohmeda, Inc. dba GE Healthcare

Datex Ohmeda, Inc: GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (C...

GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).

FDAMay 19, 2008AL, AZ, CA +30 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (C...

FDAMay 19, 2008AL, AZ, CA +30 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc. dba GE Healthcare: Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Mod...

Communication connector within monitor is defective and may cause potential loss of telemetry.

FDAMay 5, 2008Nationwide• Datex Ohmeda, Inc. dba GE Healthcare

Datex Ohmeda, Inc: GE Disposable Multi Absorber Canister used with EZchange ...

Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.

FDAJul 24, 2007Nationwide• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Ca...

Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.

FDAJul 2, 2007TX• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Engstrom Carestation Critical Care Ventilat...

There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.

FDAFeb 2, 2007GA, RI, TX +1 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an e...

There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.

FDASep 15, 2006Nationwide• Datex Ohmeda, Inc

Datex Ohmeda, Inc: Datex Ohmeda Compact Absorber, Disposable, REF 427002100,...

Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.

FDASep 11, 2006Nationwide• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging...

User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy warning signal from the Table Control TSSC interface. Inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. The alarm can be heard in the control room.

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging...

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging...

FDAAug 17, 2006AL, AZ, AR +36 more• Datex Ohmeda, Inc

Datex Ohmeda, Inc: GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery Syst...

Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.

FDAAug 10, 2006AL, AK, CA +13 more• Datex Ohmeda, Inc

Datex-Ohmeda Inc: Datex-Ohmeda Aespire Carestation. This device is not mar...

Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.

FDASep 27, 2005CA, CO, FL +12 more• Datex-Ohmeda Inc

Datex-Ohmeda Inc: Datex-Ohmeda S/5 Aespire Anesthesia System 7100

FDASep 27, 2005CA, CO, FL +12 more• Datex-Ohmeda Inc

Datex Ohmeda, Inc. dba GE Healthcare: Ohmeda Giraffe SPOT PT Lite Phototherapy System

Phototherapy medical device may lose its position and can cause a safety hazard to the patient.

FDAAug 5, 2005IN• Datex Ohmeda, Inc. dba GE Healthcare

Ohmeda Medical, A division of Datex-Ohmeda, Inc.: Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators

Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.

FDAApr 25, 2005Nationwide• Ohmeda Medical, A division of Datex-Ohmeda, Inc.