| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01212-1 |
| Product Name/Description |
Surflink Media and Surflink Media 2
Models: 200 and 210
Multiple Serial Numbers
ARTG Number: 293416 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has recently come to Starkey Laboratories' attention that specific Surflink Media and Surflink Media 2 accessories may be operating outside their permissible frequency band (915-928 MHz), and may cause interference with mobile towers (operating in the frequency band 902-915 MHz).
Any potential interference to mobile towers does not cause any interference or disruption to the accessories themselves. That is, the accessories continue to fully function/operate even though they may operate outside the frequency band 915-928 MHz. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Retailers are to quarantine affected stock then complete and return the supplied acknowledgment form.
2. Affected units should be returned as directed to Starkey Laboratories Australia.
3. Retailers are requested to forward the supplied letter to customers along with a partially-completed acknowledgement form for the customers actioning.
4. End-users should complete the supplied Recall for product Correction form, then return the accessory (not the hearing aid) to Starkey directly (using the prepaid bag), or return the accessory to the clinic where it was purchased.
5. Starkey will update the firmware and return the units to customers.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 024 985 - Starkey Laboratories Customer Service |