Software Problem with Hamilton-G5 Ventilator Results in Second Class 1 Recall in 2015Nov 11, 2015
Recalled Software Problem of Hamilton Ventilator
Hamilton Medical has recalled 1,128 Hamilton-G5 ventilators because a software problem can unintentionally suppress ventilation alarms.
The recall, posted on November 4, is the second Class 1 recall of Hamilton Medical ventilators this year, FierceMedicalDevices reports. The Food and Drug Administration (FDA) notice explains that the activation of a suctioning maneuver by the operator of the Hamilton-G5 ventilator can result in the unintentional suppression of ventilation and alarms, whether the ventilator is being used for a neonatal, a pediatric, or an adult patient.
The Hamilton-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients, according to the FDA.
Class 1 recall is the FDA’s most serious category, and is reserved for situations in which there is a reasonable probability that use of the device will cause serious adverse health consequences or death. The current recall covers the ventilators with software versions between V2.00 and 2.31. A list of serial numbers of recalled models can be found on the FDA web site.
Affected Customer of Hamilton Medical Devices Has Been Notified
In April, Hamilton notified affected customers of the problem by letter that identified the product, the problem, and the action to be taken. In June, the FDA posted a Class 1 recall notice for the Hamilton-G5 ventilators with software versions V2.40 and 2.41. That recall was based on customer reports that the ventilator display could freeze, causing the machine to stop operating and data no longer display on the screen, FierceMedicalDevices reports.
In 2013, the FDA issued a Class 1 recall for Hamilton-T1 ventilators with software versions 1.12 and lower because software problems could cause the miscalculation of the oxygen needed. The T1 is a transport ventilator, certified for use in ambulances, airplanes, and helicopters. According to FierceMedicalDevices, the last two years have seen Class 1recalls of ventilators made by CareFusion, Covidien, and Philips Respironics.