{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Ballerup", "state": "", "country": "Denmark", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "83906", "recalling_firm": "GN Hearing A/S", "address_1": "Lautrupbjerg 7", "address_2": "", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Telephone", "distribution_pattern": "Nationwide", "recall_number": "Z-0583-2020", "product_description": "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", "product_quantity": "590 units", "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.", "recall_initiation_date": "20190918", "center_classification_date": "20191127", "termination_date": "20230531", "report_date": "20191204", "code_info": "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 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 21. LT561-DRWZ, Serial Numbers: 1826294566 1826294569 1826314542 1826536990 1826564106 1826689932 1886162949 1886162964 1886163024 1886163025 1886439148 1926387800 1926398537 22. LT562-DRW, Serial Numbers: 1786525769 1826050125 1826050125 1849062977 1856138558 1856934697 1866056429 1949082660 1956355725 23. LT588-DW, Serial Numbers: 1856461081 1956645249 24. LT761-DRW, Serial Numbers: 1726834914 1786206123 1786246649 1786282552 1786282572 1786342064 1786342073 1786342082 1786389548 1786389549 1786417999 1786546750 1786561396 1786583750 1786677164 1849085499 1856083605 1856083606 1856232206 1856301721 1856301722 1856302448 1856302458 1856332109 1856408309 1856408310 1856779391 1856779392 1856791402 1856791403 1856846088 1856910652 1856910660 1856910964 1886356796 1949246336 1949246336 1956262318 1956703854 25. LT761-DRWZ, Serial Numbers: 1826251233 1826268030 1826664974 1826729924 1826734624 1826918009 1886422941 26. LT762-DRW, Serial Numbers: 1726922012 1726922012 1786465153 1786465154 1786500538 1786537239 1786537242 1826882495 1826882495 1856109990 1856158606 1856354794 1856395225 1856700781 1856700782 1856728285 1856831584 1886078171 27. LT777-DW, Serial Numbers: 1856789095 28. LT788-DW, Serial Numbers: 1886131694 29. LT961-DRW, Serial Numbers: 1726431222 1726811453 1726815850 1726815852 1726894815 1726975251 1726986475 1786076563 1786115021 1786255773 1786255793 1786383674 1786383675 1786437604 1786437605 1786466503 1786531755 1786531756 1786553946 1786554261 1786560115 1786560116 1786566901 1786582315 1786582316 1786592501 1786616744 1786638946 1786662979 1786697376 1826020211 1826020417 1826066582 1826071623 1826131347 1826165842 1826171186 1826171187 1826171360 1826182658 1826182658 1826182659 1826182659 1826247276 1826250300 1826258694 1826258716 1826365801 1826398248 1826398522 1826411442 1826421015 1826421016 1826457534 1826474580 1826487815 1826501132 1826513006 1826513007 1826517072 1826517073 1826554095 1826577367 1826585144 1826594834 1826612036 1826612037 1826619427 1826619644 1826619776 1826620172 1826728011 1826728012 1826748410 1826762330 1826762331 1826778816 1826785279 1826797375 1826797430 1826814937 1826814938 1826847671 1826915493 1826915803 1826930849 1826967473 1826967474 1826973742 1849073574 1849085394 1849085395 1849131305 1856348526 1856466682 1856713015 1886037461 1886037867 1886050764 1886050765 1886089739 1886095699 1886183487 1886183488 1886407546 1886422304 1886422305 1886422363 1886422363 1886473595 1926029402 1926287413 1926317696 1926346664 1926346674 1926657880 1926721761 1926738622 1926775132 1926928543 1926928544 1956709012 1956722069 1986031395 30. LT961-DRWZ, Serial Numbers: 1786291169 1786291170 1786301413 1786301414 1786663498 1826046735 1826131700 1826132449 1826132450 1826144980 1826144981 1826145110 1826177597 1826251150 1826383662 1826383697 1826383698 1826384075 1826384157 1826508002 1826716036 1826716084 1826805195 1826809812 1826891980 1826892154 1826897896 1849080075 1849080076 1886109834 1886155069 1886228775 1886411912 1986031591 31. LT962-DRW, Serial Numbers: 1726449301 1726449301 1726832162 1726892133 1786174132 1786216670 1786323411 1786473254 1786543401 1786614764 1786614888 1786615099 1786615120 1786638188 1786643017 1786660973 1826094949 1826184427 1826397417 1826408007 1826464030 1826495633 1826495634 1826552543 1826738380 1826738462 1826738463 1849112924 1856203911 1886012965 1886071840 1886071841 1886149702 1886365528 1886397262 1886397367 1886413624 1886422101 1886422163 1886435057 1886463199 1886463245 1886485917 1886485918 32. LT967-DW, Serial Numbers: 1926274867 33. LT977-DW, Serial Numbers: 1786534910 1826006651 1826168739 1826541619 1886257126 1886543382 1926360689 1926360689 1926360690 1956479954 34. LT988-DW, Serial Numbers: 1726427412 1786452372 1826080233 1826628934 1856648821 1886263552 1926490599 1949013609 35. TST1763-DRW, Serial Numbers: 1726695857 1726742534 1726980864 1756744917 1756745481 1756781518 1756851052 1756851109 1756857200 1756857363 1849118061 1850533038 1856040738 1856097109 1856186795 1856186852 1856430143 1856430144 1856505357 1856529914 1856553200 1856553201 1856690770 1856690771 1856781835 1866051137 1950430504 36. TST1764-DRW, Serial Numbers: 1726876110 1726876111 1756793402 1756805381 1850541672 1856153923 1856242814 1856394986 1856457509 1856569935 1856690569 1856690597 1950110050 37. TST663-DRW, Serial Numbers: 1756873621 1856363458 1856828257 1856828258 1956262225 1956262226 38. TST963-DRW, Serial Numbers: 1726759033 1726836427 1750432419 1756745922 1786135343 1826945719 1826945720 1856177429 1856245412 1856297921 1856321314 1856321315 1856564018 1856722302 1856852504 1856860883 1949236904 39. TST964-DRW, Serial Numbers: 1726831324 1726831324 1726869590 1856967305 40. VA861-DRW, Serial Numbers: 1886428470 1886428480 1926012361 1926120771 1926137351 1926378652 1926782409 1926782410 1949143448 41. VA861-DRWZ, Serial Numbers: 1886320584 1886320585 1886328314 1886334105 1886346908 1886367179 1886423902 1886423903 1886428513 1886439613 1926088858 1926260503 1926292875 1926293180 1926306456 1926312091 1926312299 1926329841 1926329841 1926329842 1926355878 1926374740 1926374741 1926513403 1926513512 1926513742 1926513743 1926588223 1926775428 1949100572 1949120317 1949120394 42. VA862-DRW, Serial Numbers: 1926190108 1926190109 1926487690 1926514381 1926664836 1949154994 1949186304", "more_code_info": "" } ] }