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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

22

Class I (Serious)

2

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 161–180 of 382 recalls

GE Healthcare, LLC: Discovery NM670 Pro Model # H3100XB

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

GE Healthcare, LLC: NM 830 Model # H3910AC

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

GE Healthcare, LLC: NM/CT 870 DR Model # H3100AS

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

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GE Healthcare, LLC: NM/CT 850 Model Number: H3907AD

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

GE Healthcare, LLC: Discovery 670 DR Model # H3100BT

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

GE Healthcare, LLC: NM/CT 870 CZT Model # H3906CW

Rotor bearing screws were found loose on detector.

FDAAug 14, 2020AR, CT, FL +24 more• GE Healthcare, LLC

Merge Healthcare, Inc.: Merge PACS

Measurements done on the Merge PACS generated MPR s may have incorrect measurements.

FDAAug 6, 2020AR, CA, CT +22 more• Merge Healthcare, Inc.

GE Healthcare, LLC: CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator ...

The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.

FDAJul 14, 2020Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CARESCAPE ONE, Physiological Patient Monitor - Product Us...

CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.

FDAJun 22, 2020Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: CARESCAPE Patient Data Module (PDM) used with the followi...

The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection is turned ON, on the monitor, and if an Automated External Defibrillator (AED) is used to perform defibrillation, the low frequency signals deployed by the AED, cause the PDM to issue a false flat line ECG waveform and alarm Asystole to be displayed on the monitor.

FDAMay 18, 2020Nationwide• GE Healthcare, LLC

Ge Healthcare: The OEC 9900 C-Arm is designed to provide fluoroscopic an...

GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live update screen from AKR / CAK to DAP. All systems sold to customers in the US that leave GEHC Surgery (the place of manufacture) are configured to display AKR / CAK when they leave the factory. An FSE changing the dose display, per the customer request, to display DAP instead does not comply to 21CFR 1020.32(k), which requires fluoroscopic equipment manufactured on or after June 10, 2006 to display continuous updates of AKR and CAK values.

FDAMay 8, 2020Nationwide• Ge Healthcare

Merge Healthcare, Inc.: Merge Healthcare Merge Application Server Software Releas...

An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.

FDAMay 8, 2020Nationwide• Merge Healthcare, Inc.

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

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 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 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.

FDAApr 2, 2020Nationwide• GE Healthcare, LLC

CHANGE HEALTHCARE CANADA COMPANY: McKesson Cardiology ECG Management, Change Healthcare Car...

Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

FDAFeb 10, 2020Nationwide• CHANGE HEALTHCARE CANADA COMPANY

GE Healthcare, LLC: SIGNA Pioneer 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 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 -...

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