Nicolet Ambulatory EEG
FDA Recall Z-2568-2018 · Posted None
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Recalling FirmNatus Neurology Inc
Recall StatusTerminated
Product CodeOLV
Date Initiated2018-02-01
Date Terminated2022-10-21
Product Quantity171 units
Reason for Recall
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Firm 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 applicable users and complete and return the verification form.
Root Cause
Software design
Distribution Pattern
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, Vietnam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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