GE Healthcare GE Senographe Pristina - Product Usage: Senographe Pristina generates digital recall — FDA Z-2131-2019
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
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.
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report…
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the…
The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle or the…
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
GE Healthcare PET/CT Table Stop Without Stopping X-Ray Exposure
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.
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.