FDA Device recall Z-0584-2020
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-…
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-… 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-0584-2020 |
| 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
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-UP, LT7CIC-HP, LT7CIC-LP, LT7CIC-MP, LT7CIC-W-MP, LT7IIC-LP, LT7ITC-DW-LP, LT7ITC-DW-MP, LT7ITC-MP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITE-DW-HP, LT7ITE-DW-MP, LT7ITE-DW-UP, LT7ITE-W-UP, LT7MIH-W-HP, LT7MIH-W-LP, LT7MIH-W-MP, LT9CIC-HP, LT9CIC-MP, LT9CIC-W-MP, LT9IIC-LP, LT9ITC-DW-HP, LT9ITC-DW-LP, LT9ITC-DW-MP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-DW-UP, LT9MIH-HP, LT9MIH-MP, LT9MIH-W-HP, LT9MIH-W-LP, LT9MIH-W-MP, TST17IIC-LP, TST17ITC-DW-HP, TST17ITE-HP, TST17MIH-W-UP, TST6CIC-HP, TST6IIC-LP, TST6ITC-MP, TST6ITC-W-HP, TST6ITC-W-MP, TST6ITE-DW-UP, TST6ITE-HP, TST6ITE-W-UP, TST6MIH-W-HP, TST9ITC-DW-MP, TST9ITE-DW-HP, TST9ITE-MP, TST9MIH-W-MP, VA8CIC-HP, VA8CIC-MP, VA8IIC-LP, VA8ITC-DW-HP, VA8ITC-DW-MP, VA8ITC-W-MP, VA8ITE-D-HP, VA8ITE-DW-HP, VA8ITE-DW-UP, VA8MIH-W-MP
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 | ITE Model Numbers 1. T9ITC-DW-LP, Serial Numbers: 1803042525 2. FT6ITC-D-MP, Serial Numbers: 1703186476 3. FT6ITE-D…ITE Model Numbers 1. T9ITC-DW-LP, Serial Numbers: 1803042525 2. FT6ITC-D-MP, Serial Numbers: 1703186476 3. FT6ITE-D-MP, Serial Numbers: 1803046347 4. FT8CIC-MP, Serial Numbers: 1903001780 5. FT8ITC-W-HP, Serial Numbers: 1703204072 6. FT8ITC-W-LP, Serial Numbers: 1803082537 7. FT8ITC-W-MP, Serial Numbers: 1803001903, 1803162395 8. FT8ITE-DW-HP, Serial Numbers: 1803007441 9. FT8MIH-W-HP, Serial Numbers: 1803099905, 1803105154 10. FT8MIH-W-MP, Serial Numbers: 1703187560 1803010468 1803010468 1803050131 1803088032 1803088032 1803088033 1803110197 11. LT5CIC-MP, Serial Numbers: 1703112759 1703112759 1803128423 1903035093 1903035093 1903035093 1903035093 12. LT5CIC-UP, Serial Numbers: 1903067660 13. LT5IIC-LP, Serial Numbers: 1903080274, 1903080275 14. LT5ITC-DW-MP, Serial Numbers: 1703127304 1703130569 1903042498 1903071182 15. LT5ITC-DW-UP, Serial Numbers: 1703170623, 1703170623 16. LT5ITE-DW-HP, Serial Numbers: 1703177839, 1703177839, 1703192785 17. L |
|---|
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-0584-2020%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.