Nicolet¿ Ambulatory EEG
Reported: August 8, 2018 Initiated: February 1, 2018 #Z-2568-2018
Product Description
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.
Details
- Recalling Firm
- Natus Neurology Inc
- Units Affected
- 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, Vietnam.
- Location
- Middleton, WI
Frequently Asked Questions
What product was recalled? ▼
Nicolet¿ Ambulatory EEG. Recalled by Natus Neurology Inc. Units affected: 171 units.
Why was this product recalled? ▼
Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 8, 2018. Severity: Moderate. Recall number: Z-2568-2018.
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