Recall Z-0583-2020
GN Hearing A/S · initiated September 18, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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 1826078212 1826319832 1826319844 1826384415 1826394747 1826412910 1826426853 1826428482 1826428482 1826428868 1826520235 1826521329 1826521330 1826665435 1826698784 1826752556 1826752557 1826827107 1826827165 1826827166 1826877557 1826886356 1826886357 1826926052 1826958345…
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0583-2020
- Initiated
- September 18, 2019
- Terminated
- May 31, 2023
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Quantity
- 590 units
- Distribution
- Nationwide
- Recalling firm
- GN Hearing A/S, Ballerup
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0584-2020 Class II | In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP…GN Hearing received reports from our manufacturing site in US regarding a software bug in our service &… | 09/18/2019Terminated |