Puritan Bennett 980 Series Ventilator (Suspended from the ARTG for a 6 month period under section 41GA(1)(a)(i) of the Act)
Product name
Puritan Bennett 980 Series Ventilator
Sponsor
ARTG
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Suspended from the ARTG for a 6 month period under section 41GA(1)(a)(i) of the Act
Grounds for regulatory action
Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register.
Revocation of suspension effective 23 August 2018.
Under section 41GD, the grounds for suspending this kind of device from the ARTG under subsection 41GA(1)(a)(i) no longer applies.