Covidien has issued a Class 1 recall of certain Nellcor Puritan Bennett 980 Ventilator Systems due to 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 cause serious health problems or death.
The Nellcor Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children and premature babies that weigh at least 10.6 ounces, and is used in hospitals and during patient transport.
The ventilators recalled include Nellcor Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through Aug. 22, 2014.
Covidien has sent Urgent Field Corrective Action letters to its customers informing them that a representative will update the software as soon as possible. The ventilators can continue to be used as long as two gas sources are connected to the ventilator at all times.
Any adverse events or quality issues involving this device should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
A Class 1 recall is the most serious type of recall issued and involves situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.