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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

85

Past Year

0

Class I (Serious)

0

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 1–20 of 85 recalls

GE Healthcare, LLC: (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX...

Inaccurate Distance and Area measurements with use of Global Stack viewport.

FDAJul 15, 2022AZ, AR, CA +37 more• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Premier magnetic resonance scanner, model 5748519.

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

FDAJun 24, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: GE Centricity Universal Viewer Zero Footprint. To view,...

Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)

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Nationwide

• GE Healthcare, LLC

GE Healthcare, LLC: Service manuals for the CT, PET, or NM table as follows: ...

As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

FDAJun 2, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Syste...

The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

FDAMay 27, 2022AZ, CA, CO +25 more• GE Healthcare, LLC

GE Healthcare, LLC: CARESCAPE Central Station (CSCS) V2, Model numbers 208227...

The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station.

FDAMay 10, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity PACS RA1000

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity Radiology RA600

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity Universal Viewer Zero Footprint Client

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity Cardiology CA1000

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Centricity Enterprise Web

Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.

FDAApr 28, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Back up batteries in Avance CS2 and Avance CS2 Pro anesth...

Backup batteries can fail earlier than their estimated life.

FDAApr 25, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Field replacement back up batteries distributed on or aft...

Backup batteries can fail earlier than their estimated life.

FDAApr 25, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Replacement back up batteries distributed on or after Apr...

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

FDAApr 18, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Back up batteries in Ventilators labeled as the following...

Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.

FDAApr 18, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: MUSE Cardiology Information System, Model Numbers: a) 31...

Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

FDAMar 16, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: GE Healthcare MR Systems, Magnetic Resonance imaging (MRI...

During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.

FDAMar 4, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Res...

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

GE Healthcare, LLC: SIGNA Excite 3T. Magnetic Resonance Imaging System

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC