Z-2553-2019Class II

Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2...

Name: Z-2553-2019 Gold Cup Leadwire and Snap Leadwire with the following component descriptions: 1. 24" Snap Leadwire, Blue; 2...
Creator: GN Otometrics
Published: 2019-08-01
License: https://open.fda.gov/license/

Natus Medical Denmark ApS / initiated 2019-08-01 / Open, Classified / root cause: software

FDA source

GN Otometrics began a recall of 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... on 2019-08-01. FDA classified it as Class II and gives the reason as "The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2553-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-01
Posted: 2019-09-23
Recalling firm: Natus Medical Denmark ApS
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.
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Reason for recall: The electrode lead connector has a protruding conductor beyond insulation of approximately 0.1 mm.
Root cause tag: software
FDA 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 [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2553-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2553-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code DSA

K080112Class IIPatient CableMed-Dyne / cleared 2008-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)