Reported Dec 4, 2019 · Terminated
Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH,…
GN Hearing A/S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GN Hearing A/S · Lautrupbjerg 7 · Ballerup · N/A
Is this the product you have?
- Behind-the-Ear hearing aids
- Model Numbers
Q962-DRWT561-DRWT562-DRWT762-DRWT777-DWAMZ964-DRWET588-DWHET598-DWET788-DWHET798-DWET988-DWHET998-DWFT861-DRWFT862-DRWRE561-DRWCRE762-DRWRE961-DRWCRE962-DRWPZ862-DRWLT561-DRWLT561-DRWZLT562-DRWLT588-DWLT761-DRWLT761-DRWZLT762-DRWLT777-DWLT788-DWLT961-DRWLT961-DRWZLT962-DRWLT967-DWLT977-DWLT988-DWTST1763-DRWTST1764-DRWTST663-DRWTST963-DRWTST964-DRWVA861-DRWVA861-DRWZVA862-DRW
- Lot codes and dates
42 of 42 products
Products covered by this recall # Product as published 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 1826958346 1826982966 1849076807 1849098981 1849103936 1886024051 1886075478 1886090034 1886288630 1886288631 1886422772 1949110545 1949178118 1949194578 1949194578 1949244608 14 FT862-DRW, Serial Numbers: 1826002195 1826108576 1826147261 1826206052 1826206056 1826266399 1826331700 1826349318 1826418888 1826663906 1826663907 1826902422 1826902453 1826935603 1826954235 1886387429 1886387430 1926019399 1926173465 1949006883 1950535217 15 RE561-DRWC, Serial Numbers: 1956481867 16 RE762-DRW, Serial Numbers: 1950393987 17 RE961-DRWC, Serial Numbers: 1886200466 1926008396 18 RE962-DRW, Serial Numbers: 1886355785 1886441408 1886469138 1886469160 1886469160 1886469161 1926059398 1926138562 1926138562 1926293595 1926312455 1926312455 1926312458 1926312458 1926379189 1926379190 1926524934 1926524935 1926582267 1926582297 1926610094 1926610094 1926610094 1956112706 1956223504 19 PZ862-DRW, Serial Numbers: 1926887334 1926974193 1926974194 20 LT561-DRW, Serial Numbers: 1726858453 1726858454 1726980253 1786148930 1786271586 1786271587 1786385326 1786412489 1786431386 1786431388 1786466248 1826021147 1826021148 1826475196 1826507406 1826507407 1856579352 1856761289 1856761290 1856922052 1856922053 1866000994 1950565297 - Amount recalled
- 590 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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