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Covidien Recalls Nellcor Puritan Bennett 980 Ventilators Recalled for Software Problem

Nov 13, 2014

Covidien has initiated the recall of the Nellcor Puritan Bennett 980 Ventilator System with software versions below 2.8, according to a safety alert from the Food and Drug Administration (FDA).

The recalled ventilators may have a software problem that can cause them to stop working after the air and oxygen gas supply lines are disconnected and then reconnected. Use of these ventilators can lead to serious health problems or death "if the health care provider does not connect the patient to another ventilator or to a different form of breathing support," according to the FDA. The ventilators are used in hospitals and during patient transport to provide breathing support for babies, children, and adults.

This is a Class I recall, the FDA’s most serious recall category, reserved for situations where there is a “reasonable probability” that use of the device may result in serious health problems or death.

The recall applies to ventilators manufactured from March 3, 2014 to Aug. 19, 2014 and distributed until Aug. 22, 2014. The FDA web site contains a full list of serial numbers.

Covidien will send representatives to update the faulty software, but advises customers that they can continue to use the ventilators until they receive the software update as long as two gas sources are connected to the device at all times. The FDA advises close monitoring of patients on ventilators and having another source of breathing support nearby when using the ventilator.

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