FDA recall Z-1440-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2020-02-06

Report date

2020-03-11

Termination date

2022-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2020