Z-1440-2020 Class II Terminated

Recalled by Invivo Corporation — Gainesville, FL

Recall Details

Product Type
Devices
Report Date
March 11, 2020
Initiation Date
February 6, 2020
Termination Date
May 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
75

Product Description

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Reason for Recall

Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

Distribution Pattern

U.S Distribution: AK, AL, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX and WV. *** Foreign: Australia, Canada, France, United Kingdom, Italy, Japan, Netherlands, Saudi Arabia, India and Thailand.

Code Information

9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI