FDA Alerts

Class 1 Recall: Nellcor Puritan Bennett, 980 Ventilator System - Software Issue May Stop Ventilator

Puritan Bennett 980 Ventilator Systems with software versions below 2.8 may have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected.

Wed Oct 01 2014By Kaylee McCaffrey

Recall Class: Class I

Date Recall Initiated: October 1, 2014

Devices: Puritan Bennett 980 Ventilator System

  • Manufacturing Dates: March 3, 2014 through August 19, 2014
  • Distribution Dates: March 3, 2014 through August 22, 2014

See list of recalled serial numbers.

Use: The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and premature babies that weigh at least 10.6 ounces. The ventilator is used in hospitals or during patient transport.

Recalling Firm: 
Nellcor Puritan Bennett Inc. (doing business as Covidien LP)
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214

Reason for Recall: Puritan Bennett 980 Ventilator Systems with software versions below 2.8 may have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death if the healthcare provider does not connect the patient to another ventilator or to a different form of breathing support.

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