Federal healthcare regulators put their highest-risk Class I label on a recall of GE Healthcare’s (NYSE:GE) ventilators and anesthesia systems, warning that an issue with unresponsive buttons could delay vital treatment and leave patients injured or even dead.
GE earlier this year warned that certain of its Engström ventilators and Aespire View, Aisys, and Avance anesthesia machines suffered manufacturing issues that could leave certain keypad buttons intermittently unresponsive, preventing care-givers from accessing important menu options.
"This may result in the inability to access certain menu functions which could possibly lead to a delay in treatment and may cause serious adverse health consequences, including death," according to the FDA notice.
GE late in August notified customers of the potential issue, advising them to try alternative methods of accessing desired menus if pressing and re-pressing the buttons fails to work. If the alternative "control wheel" doesn’t solve the problem, GE advised customers to call the company to arrange for free correction of any affected systems.
The warning marks the 2nd GE alert in recent weeks, with the company warning earlier this month of a software issue in certain of its Avance, Avance CS2 and Aisys anesthesia delivery systems. GE said it may need to issue a field correction for a potential software issue that may cause the affected devices to deliver higher-than-expected tidal volumes when in "Pressure Control Ventilation – Volume Guarantee" mode.