GN Otometrics: Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

Recall number

Z-2553-2019

Recalling firm

GN Otometrics

Product

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2. 40" Snap Leadwire, Blue; 3. 24" Snap Leadwire, Red; 4. 40" Snap Leadwire, Red; 5. 24" Snap Leadwire, Green; 6. 40" Snap Leadwire, Green; 7. 24" Snap Leadwire, Brown; 8. 40" Snap Leadwire, Brown; 9. 24" Snap Leadwire, Orange; 10. 40" Snap Leadwire, Orange; 11. 24" Snap Leadwire, White; 12. 40" Snap Leadwire, White; 13. 24" Snap Leadwire, Black; 14. 40" Snap Leadwire, Black; 15. 24" Snap Leadwire, Yellow; 16. 40" Snap Leadwire, Yellow; 17. 24" Snap Leadwire, Set of 5; 18. 24" Snap Leadwire, Set of 7; 19. 40" Snap Leadwire, Set of 5; 20. 40" Snap Leadwire, Set of 7; 21. 24" Snap Leadwire, Set of 5; 22. 40" Snap Leadwire, Set of 5; 23. 48" Gold Cup Leadwires, Blue; 24. 48" Gold Cup Leadwires, Red; 25. 48" Gold Cup Leadwires, Green; 26. 48" Gold Cup Leadwires, Brown; 27. 48" Gold Cup Leadwires, Orange; 28. 48" Gold Cup Leadwires, White; 29. 48" Gold Cup Leadwires, Black; 30. 48" Gold Cup Leadwires, Yellow; 31. 48" Gold Cup Leadwires, Set of 5; 32. 48" Gold Cup Leadwires, Set of 8; Product Usage: The snap electrode leads are used in conjunction with disposable electrodes and the Gold Cup electrodes are reusable electrodes and leads. Both types of electrodes and leads are used for evoked potential testing for audiological, neurological and/or vestibular testing. The electrode leads are connected to the main device by the electrode lead connector and the electrode is attached to the patient contact end of electrode lead.

Status

Open, Classified

Initiated

2019-08-01

Posted

not on file

Terminated

not on file

Reason

The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.

Root cause

Software design (manufacturing process)

Action

GN Otometrics notified customers on about 08/01/2019 via "URGENT FIELD SAFETY NOTICE (FSN) MEDICAL DEVICE RECALL" letter. The notification informed customers that the electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm and there is potential risk to healthcare professionals or patients of exposure to electrical shock form the electrode connector. Instructions included to identify, cease use and quarantine the affected electrode leads, ensure all personnel are notified who need to be aware, notify customers if the affected electrode leads have been further distributed, and arrange for the return of affected electrode leads to Natus Medical, 3150 Pleasant View Lane, Middleton, WI 53562. Customers were also instructed to complete and return the Customer Reply Form via email to otochartrLeads.US@natus.com or fax to 1-847-557-1308.

Quantity

4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)

Distribution

Worldwide distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cote D'ivoire, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Lebanon, Luxembourg, Macedonia, The Former Yugoslav, Malaysia, Maldives, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Zimbabwe.

Lot, serial or model codes

Part Numbers:   1. 7590310-24;   2. 7590310-40;   3. 7590311-24;   4. 7590311-40;   5. 7590312-24;   6. 7590312-40;   7. 7590313-24;   8. 7590313-40;   9. 7590314-24;   10. 7590314-40;   11. 7590315-24;   12. 7590315-40;   13. 7590316-24;   14. 7590316-40;   15. 7590317-24;   16. 7590317-40;   17. 7590318-24-5;   18. 7590318-24-7;   19. 7590318-40-5;   20. 7590318-40-7;   21. 7590319-24-5;   22. 7590319-40-5;   23. 7590440;   24. 7590441;   25. 7590442;   26. 7590443;   27. 7590444;   28. 7590445;   29. 7590446;   30. 7590447;   31. 7590450-5;   32. 7590450-8

510(k) numbers

["K080112"]

PMA numbers

not on file

Product code

DSA

Firm FEI

3002807554

Firm city

Taastrup

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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