Oticon Medical A Division of Audmet Australia Pty Ltd — The Neuro Zti EVO and CLA Cochlear Implants

PRA number

2021/19253

Published date

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)

Reasons the product is recalled

The implant may stop working due to a complete loss of communication between the implant and the sound processor.

The hazards to consumers

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 consumers should 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.

Traders who sold this product

Audiologists

Where the product was sold

New South Wales
Queensland
South Australia
Western Australia

Dates available for sale

-

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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