Recall Z-0583-2020 ยท ESD Hearing Aid, Air-Conduction, Prescription
GN Hearing A/S
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-
| Date | Sep 18, 2019 |
| Status | Terminated |
| Reason | GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported. |
| Root cause | Other |
| Action | The firm initiated the recall by telephone on 09/18/2019 and followed with a letter customized to each consignee. The requests the return of the affected units. The letter also requests that any entity that distributed the product notify their customers. |
| Quantity | 590 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.