The Neuro Zti EVO and CLA Cochlear Implants
Reason for Recall / Hazard
The implant may stop working due to a complete loss of communication between the implant and the sound processor.
Product Description & Identification
Reason / Defects: The implant may stop working due to a complete loss of communication between the implant and the sound processor. 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 to 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 32ef6c2f-389d-4a00-b05e-db176de898f4 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/the-neuro-zti-evo-and-cla-cochlear-implants |
| Pub Date | Thu, 18 Nov 2021 00:00:00 +0000 |