FDA recall Z-2568-2018

Product

Nicolet¿ Ambulatory EEG

Reason for recall

Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

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, Vietnam.

Key facts

Status

Terminated

Initiation date

2018-02-01

Report date

2018-08-08

Termination date

2022-10-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Middleton, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2568-2018