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U.S. Department of Health and Human Services

Class 2 Device Recall Gold Cup Electrode and Snap Electrode Leads

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  Class 2 Device Recall Gold Cup Electrode and Snap Electrode Leads see related information
Date Initiated by Firm August 01, 2019
Create Date September 23, 2019
Recall Status1 Open3, Classified
Recall Number Z-2553-2019
Recall Event ID 83491
510(K)Number K080112  
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
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.
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 
Recalling Firm/
Manufacturer		 GN Otometrics
Horskatten 9
Taastrup Denmark
Manufacturer Reason
for Recall		 The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSA and Original Applicant = MED-DYNE
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