Recall Z-2568-2018 ยท OLV Standard Polysomnograph With Electroencephalograph
Natus Neurology Inc
Nicolet Ambulatory EEG
| Date | Feb 1, 2018 |
| Status | Terminated |
| Reason | Potential to be able to import an ambulatory exam for a patient for which the exam was not started. |
| Root cause | Software design |
| Action | Customers were notified via letter on about 02/01/2018. Instructions to ensure the empty exam is removed appropriately after starting the ambulatory recording included: 1) Only shutdown Recorder via the Recorder UI, either from the File menu or the X button on the top right of the application; 2) If any of the four conditions above occurs and the 2.60 MB exam is not removed, the empty exam can be deleted from NicVue prior to importing the ambulatory exam, doing so will allow the patient ID check to occur normally. Customers were also instructed to provide the recall communication to all app |
| Quantity | 171 units |
| Distribution | Distributed domestically to AR, AZ, CA, CO, DC, FL, GA, ID, IL, IN, MA, ME, MI, MO, N Y, NC, ND, NJ, NV, NY, PA, TN, TX, VA, WA, WI. Distributed internationally to Australia, Belgium, China, Germany, Hong Kong, Israel, Italy, Jordan, Kuwait, Russia, Slovenia, Tunisia, United Arab Emirates, Vietna |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021185 | NERVUS MONITOR Taugagreining HF, Jul 12, 2002 |