device · product 1 of 1
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
- Initiated
- August 01, 2019
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- GN Otometrics
- Quantity
- 4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)
App-derived interpretation
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Official device-enrichment evidence · Sourced
Software design (manufacturing process)
Inspect official wording and provenance
Reason for recall
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Code information
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
Distribution pattern
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.