FDA Device recall Z-0583-2020
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, ET…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of 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, ET… by Gn Hearing A S, citing 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 li….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0583-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-18 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gn Hearing A S |
| Distribution | US |
Product
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-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW
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.
Identifiers
| code_info | BTE Model Numbers 1. Q962-DRW, Serial Numbers: 1956267136 2. T561-DRW, Serial Numbers: 1826333136 3. T562-DRW, Se…BTE Model Numbers 1. Q962-DRW, Serial Numbers: 1956267136 2. T561-DRW, Serial Numbers: 1826333136 3. T562-DRW, Serial Numbers: 1926268020 1926268023 4. T762-DRW, Serial Numbers: 1786530800 1786530800 1786530800 1786530800 5. T777-DW, Serial Numbers: 1856523922 6. AMZ964-DRW, Serial Numbers: 1886309928 1886309928 7. ET588-DWH, Serial Numbers: 1826694045 1886574434 1926917354 8. ET598-DW, Serial Numbers: 1826548362 1826548363 1826558523 1826558524 1886035343 1956138156 1956674808 1956674811 9. ET788-DWH, Serial Numbers: 1786681686 1949058624 10. ET798-DW, Serial Numbers: 1786671213 1826213864 1866083875 11. ET988-DWH, Serial Numbers: 1786702037 1826417609 1826605822 1886295047 1926360970 12. ET998-DW, Serial Numbers: 1826235478 1826558443 1826758611 1826863215 1826922716 1849162491 1866019090 1886543814 1926084437 13. FT861-DRW, Serial Numbers: 1786441534 1786441535 1786513836 1786575879 1826005162 1826072467 1826078 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0583-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.