Class 1 Recall: Covidien, Puritan Bennett 840 Series Ventilator - Software Problem
Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.
Mon Dec 16 2013
Recall Class: Class I
Date Recall Initiated: December 16, 2013
Product(s): Puritan Bennett 840 Series Ventilator
Model/catalog/lot numbers: Software Part Number 4-070212-85, Revision AB-AG
Range of manufacturing and distribution dates:
Manufactured: April 30, 1998 to March 12, 2010
Distributed: August 1, 2008 to October 31, 2010
Use: A critical care ventilator that provides continuous ventilation for infant, pediatric, and adult patients.
Recalling Firm:
Covidien
6135 Gunbarrel Avenue
Boulder, Colorado 80301-3214
Reason for Recall: Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death.
Public Contact: Customers with questions regarding this recall can contact Covidien Technical Services at 800-255-6774, Monday through Friday, from 6 AM to 5 PM Pacific Time (Menu option # 4). Customer service (Menu option # 3) is available Monday through Friday from 8 AM to 6:30 PM Eastern Time.
FDA District: Denver District