GE Healthcare, LLC recalls
14 recalls on record · FDA
Every recall we have on record for GE Healthcare, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Centricity PACS Software Version 7.0 SP0.0.4.7
The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.
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.
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and…
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or…
Backup batteries can fail earlier than their estimated life.
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c)…
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
There is potential for the images to be flipped left to right.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.