PlainRecalls
FDA Devices Moderate Class II Terminated

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Reported: March 11, 2020 Initiated: February 6, 2020 #Z-1440-2020

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.

Details

Recalling Firm
Invivo Corporation
Units Affected
75
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.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System. Recalled by Invivo Corporation. Units affected: 75.
Why was this product recalled?
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1440-2020.