The FDA updated the Class I recall of CareFusion‘s (NYSE:CFN) AVEA ventilators, to include those used on infants under 5.5 pounds at altitudes above 5000 feet.

The recall, originally issued in September, was attributed to the AVEA device’s potential to under-report tidal volume. Earlier this month, the federal watchdog agency updated the recall to Class I, after complaints from a neonatal care clinic.

Use of the AVEA standard ventilator should "discontinue, in the neonatal patient setting," according to the recall notice, unless it’s used in conjunction with a VarFiex single-patient-use flow sensor.

It’s not the first recall for the AVEA line, which was the subject of a Class I recall in 2011 over a potential failure in the safety valves that could result in failed ventilation. That issue spurred nearly 100 incident reports, but no deaths.