# FDA recall Z-0583-2020

> **GN Hearing A/S** · Class II · device recall initiated 2019-09-18.

## 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 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0583-2020
- **Recalling firm:** GN Hearing A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-18
- **Report date:** 2019-12-04
- **Termination date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ballerup, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0583-2020

## Citation

> AI Analytics. FDA recall Z-0583-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0583-2020. Source: US FDA. Licensed CC0.

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