GE Healthcare (NYSE:GE) issued a field correction on certain of its Avance, Avance CS2 and Aisys anesthesia delivery systems, warning that they need a software update to avoid a potential safety issue.
The healthcare giant said that the affected devices, running 8.00 or 10.00 programming, may deliver higher-than-expected tidal volumes when in "Pressure Control Ventilation – Volume Guarantee" mode.
"Over-delivery of tidal volume this may result in alterations to blood flow within the thorax that, under extreme circumstances, may result in gradual reductions in blood pressure," according to the company notice. "To date, no patient injuries have been reported with regards to this issue."
GE has issued a software update that should alleviate the issue, which occurs when certain commands are put in sequence.
"To avoid this situation, when using PCV-VG mode, do not adjust the ventilator tidal volume while in a manual ventilation mode," GE warned. "At any time during the use of the device should an over delivery of tidal volume occur while in PCV-VG mode, transitioning to a different ventilation mode will resolve the issue."