Puritan Bennett 980 Series Ventilator (Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act)
Product name
Puritan Bennett 980 Series Ventilator
ARTG
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act
Grounds for regulatory action
6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious injury or illness if the kind of device continues to be included in the ARTG.
The Minister has revoked the suspension and substituted another decision following a review of the Secretary's decision under section 60 of the Therapeutic Goods Act 1989. See further information above.