Recall Z-2039-2014 ยท LMD System, Digital Image Communications, Radiological
Karl Storz Endoscopy
Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
| Date | Jul 10, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to. |
| Root cause | Nonconforming Material/Component |
| Action | Storz sent an Safety Alert letter dated June 25, 2014, to all customers who purchased the Essential NEO. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached Acknowledgement/Response Form with contact information and return to KARL STORZ. Customers with questions are instructed to contact KARL STORZ' Technical Support Department at (800) 421-0837, option 3, then option 4. |
| Quantity | 968 units |
| Distribution | Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, District of Columbia, DE, FL, GA, HI, IA, IL, IN, KY, LA, MX, MS, MD, MI, MA, MO, MN. NM, NV, NJ, NY, NC, NE, OK, OH, PA, SC, SD, TX, UT, VA, WI and WA., and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.