GN RESOUND CHINA, LTD.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Masker, TinnitusProduct code KLW (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.3400
Recalls & enforcement
- Class IITerminated2019-09-18GN 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…
Related
- All facilities operated by GN Hearing A/S
- GN ReSound (Malaysia) Sdn Bhd. (MY)
- GN Hearing Care Corporation (MN)
- GN ReSound (Malaysia) Sdn. Bhd (MY)
- GN Hearing A/S (DK)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “GN RESOUND CHINA, LTD. (FEI 3003303986) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003303986-gn-resound-china-ltd/
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