The FDA announced on November 7 that it has notified healthcare facilities of the Class 1 recall of certain Nellcor Puritan Bennett 980 ventilator systems. The systems affected use software versions below 2.8, with distribution dates from March 3, 2014 through August 22, 2014. The agency has listed on its web site the serial numbers of the units affected. The systems recalled “have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected,” according to the agency.
In its announcement, the FDA noted that the manufacturer of the ventilator, Covidien, sent affected customers an Urgent Field Corrective Action letter on October 3, 2014. Facilities were advised that they may continue to use the ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times.
For more information on the recall, visit the FDA website.