Covidien Puritan Bennett 980 Ventilator Recalled

November 13, 2014 — The FDA has issued a Class I recall for a ventilator with defective software that can cause them to stop working.

Healthcare providers must connect the patient to another ventilator or to a different form of breathing support.

The recall affects Coviden’s Nellcor Puritan Bennett 980 Ventilator System with software version below 2.8, with distribution dates between March 3, 2014 and August 22, 2014. Click here for serial numbers.

The recalled ventilator system is used to provide constant breathing support for adults, children, and premature infants weighing at least 10.6 ounces. It is used in hospitals or during patient transport.

According to the recall notification:

“The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.”

Covidien warned customers with an “Urgent Field Corrective Action” letter on October 3, 2014. The company will send a representative to update the software on the ventilators as soon as possible.

Until the software is updated, Covidien recommends using the ventilators with two gas sources. Always keep at least one gas source connected when disconnecting and reconnecting gas sources. If the ventilator stops, provide another source of breathing.

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