Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:29179
Brand Name:MITG - Ventilator System
Model:Puritan Bennett™ 980 Series Ventilator 980A1ENNISB, 980U1ENASAA, 980U1ENASAA, 980X1ENASAA, 980X1ENASAA, 980X3ENASAA
Affected:
Software version:
Recalling Organisation:Medtronic New Zealand Limited
Unit 16 Mezzanine Level
5 Gloucester Park Road
Onehunga
AUCKLAND
Contact Information:0800 377 807
Manufacturer:Covidien LLC
Issue:The manufacturer received complaints alleging that PB980 ventilators did not annunciate an audible alarm during active alarm conditions. It was reported that the active alarm condition banner was correctly displayed on the GUI; however, the Omni-Directional LED visual alarm may not illuminate as anticipated (non-operational or incorrect colour).
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:5/4/2022
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