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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

382

Past Year

Class I (Serious)

Most Recent

Nov 2025

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 181–200 of 382 recalls

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.

FDA

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Page 10 of 20Next

Dec 3, 2019

Nationwide

• 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

GE Healthcare, LLC: CARESCAPE Respiratory Module E-sCO

Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.

FDASep 27, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Airway Gas Option N-CAiO

Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.

FDASep 27, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CardioLab/ComboLab Recording Systems

Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.

FDASep 16, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Achilles Insight Bone Sonometer

Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

FDASep 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Achilles Express Bone Sonometer

Certain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective earth connection.

FDASep 3, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: ApexPro Telemetry Server System. Also identified as Modi...

May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain conditions.

FDAAug 30, 2019Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Proteus XR/a (SlOK : K993090)

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

FDAAug 9, 2019Nationwide• GE Healthcare, LLC