Overview of recall records associated with GE Healthcare, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 236, Class I: 17, Class III: 6.
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of…
Inaccurate Distance and Area measurements with use of Global Stack viewport.
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…
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
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…
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
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…
Backup batteries can fail earlier than their estimated life.
Backup batteries can fail earlier than their estimated life.
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.
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…
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…
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…
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
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…
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…
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
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,…
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
There is potential for the images to be flipped left to right.
There is potential for the images to be flipped left to right.
There is potential for the images to be flipped left to right.
There is potential for the images to be flipped left to right.
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
This page summarizes recall records in which the official source identifies GE Healthcare, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
