| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00901-1 |
| Product Name/Description |
Cochlear Nucleus 8 Sound Processors
Product codes: P1840233, P1840723, P1840542, P1840332, P1840111, P1840403, P1840233R, P1840723R, P1840542R, P1840332R, P1840111R, P1840403R
Multiple Product Names, Serial Numbers and Dates of Manufacture.
Affected devices manufactured and repaired between June 18, 2024, and October 1, 2024
ARTG 394470 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Cochlear has recently become aware of a problem that has resulted in certain Cochlear Nucleus 8 Sound Processors not being able to pair with compatible smartphones, CR310 Remote Controls or True Wireless devices.
This problem only affects devices manufactured and repaired between June 18, 2024, and October 1, 2024, and it has no impact on the safety of the device. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
1. For existing patients affected:
a. Try the standard troubleshooting steps first,
b. If these steps are unsuccessful, the patient will need to return to the clinic so their sound processor can be reset in Custom Sound Pro 7.0, then have their MAPs re-saved (see customer letter for instructions).
2. For new Nucleus 8 Sound Processor patients upgrading or having their first fitting:
a. Perform the reset using the same steps (see customer letter) before programming any new or repaired Nucleus 8 Sound Processors.
Cochlear recommends customers reset any new or repaired processor, irrespective of the manufacturing.
Cochlear is working on an update to Custom Sound Pro Fitting Software that will ensure impacted devices no longer require the reset step to fix the pairing problem. That update is expected to be released within the next 4 to 6 weeks. |
| Contact Information |
1800 620 929 - Local Cochlear representative, Australia |