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)
See a list of details to help identify the product
Reason 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.
Details to help identify the product
Supplier running the recall
Who sold the product
Audiologists
Dates available for sale
Where the product was sold
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2021/19253 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.