The FDA has hit Covidien's ($COV) Puritan Bennett 980 Ventilator Systems with its most severe Class I recall, meaning there is a reasonable probability that use of the product will cause serious adverse health consequences or death. Ventilators with software versions below 2.8 have a problem that causes the device to stop working after air and oxygen gas supply lines are disconnected and then reconnected, the agency says. Covidien has notified customers of the defect and will update the software as soon as possible, according to the FDA's recent safety alert. Safety Alert