FDA Announces Recall of the 980 Ventilator System

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

The FDA has notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014 and serial numbers listed here. 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.

RECOMMENDATION: Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers. A Covidien representative will update the software on the ventilators as soon as possible. To receive the software update, complete the acknowledgement and receipt form attached to the correction letter. Fax it to the Covidien contact found on the form.

Customers may continue to use these ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times. See the recall notice at the link below for other Covidien reminders and instructions from the Corrective Action letter.

Read the MedWatch safety alert including a link to the Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm422362.htm

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178