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GE Healthcare, LLC

GE Healthcare, LLC Recalls

All product recalls associated with GE Healthcare, LLC.

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Recall Summary

Total Recalls

171

Past Year

Class I (Serious)

Most Recent

Jul 2022

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 101–120 of 171 recalls

GE Healthcare, LLC: Giraffe Incubator with installed Servo Oxygen module. Inf...

Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.

FDAApr 28, 2020Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe OmniBed with installed Servo Oxygen module. Infan...

FDAApr 28, 2020Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe Shuttle. Upgrade Kits with part number 2109672-00...

During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

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FDAApr 2, 2020Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, ...

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

FDADec 23, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Architect Nuclear Magnetic Resonance Imaging System...

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

FDADec 23, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Premier Nuclear Magnetic Resonance Imaging System -...

FDADec 23, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Pioneer Nuclear Magnetic Resonance Imaging System -...

FDADec 23, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity Universal Viewer 6.0, a device that displays m...

Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.

FDADec 16, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Lunar iDXA bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDADec 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) ...

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDADec 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer

An issue with the Lunar iDXA control panel may cause the start button to not release and potentially contribute to an accidental radiation occurrence.

FDADec 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Carestation 620/650/650c A2 Product Usage: anesthesia ...

GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and visual alarms. Loss of mechanical ventilation could lead to hypoxia if the clinician does not intervene.

FDANov 25, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Carestation 620/650/650c A1 Product Usage: anesthesia ...

FDANov 25, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: ApexPro Telemetry System - Product Usage: The ApexPro Tel...

When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.

FDANov 12, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CARESCAPE Central Station - Product Usage: The intended u...

FDANov 12, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CIC Pro Clinical Information Center Central Station - Pro...

FDANov 12, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe Incubator infant warmer

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

FDAOct 11, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe OmniBed infant warmer

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

FDAOct 11, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe Incubator Carestation, Giraffe Incubator Carestat...

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

FDAOct 11, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Giraffe OmniBed Carestation, Model Numbers: 2082844-001-...

Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.

FDAOct 11, 2019Nationwide• GE Healthcare, LLC