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The Neuro Zti EVO and CLA Cochlear Implants

Official notice

18 Nov 2021

Last checked

18 Nov 2021

High riskACCC

An official ACCC notice concerns The Neuro Zti EVO and CLA Cochlear Implants. 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. Published 2021-11-18.

What to do now

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.

Recall number

32ef6c2f-389d-4a00-b05e-db176de898f4

Official notice

2021-11-18

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

from, above

Artg Numbers

284148, 284150

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Affected products

Product 1

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)

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

32ef6c2f-389d-4a00-b05e-db176de898f4

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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