Swiss device maker Hamilton Medical is recalling more than 4,300 ventilators due to a software failure that shuts off the machines, according to the FDA.
Hamilton G-5 ventilators manufactured between November 29, 2007 and October 31, 2018 may display a “panel connection lost” error message that causes the machine to stop working and leaves patients to breathe ambient air unassisted. Alternative ventilation must be provided immediately, the agency said.
The user error message is due to a blocked or terminated communication between the ventilation unit processor and the interaction panel processor, according to Hamilton Medical.
The affected ventilators are used by adult, pediatric, infant and neonatal patients. The company has received 14 complaints about the error message, however no patient injury or death have been reported due to the issue. The FDA has labeled the recall Class I.
Hamilton Medical, which notified customers by letter beginning in February, has developed new software for the ventilators, the agency said.