More than 4000 Hamilton-G5 ventilators have been recalled due to a sporadic error message that can cause it to stop working, the FDA recently announced. The device provides breathing support for adult, pediatric, infant, and neonatal patients in intensive care.
The class I recall—the most serious type due to the potential for severe injury or death—was prompted by 14 complaints to the device’s manufacturer, Hamilton Medical AG of Bonaduz, Switzerland. Recalled devices may generate a “panel connection lost” error causing the ventilator to enter an ambient state. In that event, patients require immediate alternative ventilation.
No injuries or deaths have been reported. Affected devices are those with serial numbers below 16192 and software versions 2.60 or lower. Hamilton issued safety notices in February and March of 2019 alerting ventilator users of new software that reduces the chances that the error message occurs. But if it does, the manufacturer recommends that health care professionals turn the device off, monitor their patient’s safety, and provide alternate ventilation immediately. They should also contact their distributor for the updated software.