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 Initiated
- August 1, 2019
- Recall Number
- Z-2553-2019
- Quantity
- 4,882 units (41950 individual electrode leads supplied In 5,7 & 10 packs)
Reason for Recall
The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
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 / Code Info
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
Root Cause
Software design (manufacturing process)
Action Taken
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.