A recall notice for The Neuro Zti EVO and CLA Cochlear Implants supplied by Oticon Medical A Division of Audmet Australia Pty Ltd as the implant may stop working due to a complete loss of communication between the implant and the sound processor.
Oticon Medical A Division of Audmet Australia Pty Ltd - The Neuro Zti EVO and CLA Cochlear Implants
PRA number
2021/19253
Published date
18 Nov 2021
Product description
The Neuro Zti EVO and CLA cochlear implants
Zti EVO Implant:
Catalogue no: M80185
Serial number from and above NZB04074
Zti CLA Implant
Catalogue no: M80184
Serial number from and above NZA02454
ARTG 284148
(Oticon Medical A Division of Audmet Australia - Neuro ZTI CLA (M80184) - Stimulator, electrical, auditory, cochlea)
ARTG 284150
(Oticon Medical A Division of Audmet Australia - Neuro Zti EVO Cochlear Implant - Stimulator, electrical, auditory, cochlea)
What are the defects?
The implant may stop working due to a complete loss of communication between the implant and the sound processor.
What are the hazards?
If the implant stops working and shuts down and there is a loss of communication between the implant and the sound processor, users will not be able to hear sounds or instructions and this may lead to harm.
What should consumers do?
Oticon Medical will write to affected consumers to advise them of the issue and provide instructions.
Consumers should be aware of this issue and if they experience a sudden loss of communication, and the problem cannot be isolated to the external components, they should contact their audiologist to make an appointment to have the device checked and repaired.
Supplier
Oticon Medical A Division of Audmet Australia Pty Ltd
Traders who sold this product
Audiologists
Where the product was sold
New South Wales
Queensland
South Australia
Western Australia
Dates available for sale
1 Jan 2019 - 20 Oct 2021
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.
