Recall Z-2553-2019 ยท DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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.
| Date | Aug 1, 2019 |
| Status | Open, Classified |
| 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 |
| 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, Australi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080112 | PATIENT CABLE Med-Dyne, Jun 20, 2008 |