Recall Z-1440-2020— Invivo Corporation

Name: FDA recall Z-1440-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Class II · Terminated

Class II FDA medical device recall by Invivo Corporation, initiated 2020-02-06, terminated 2022-05-04. It names one FDA 510(k) clearance: K023130. Product: Monitor for the Functional Imaging System for Magnetic Resonance Imaging System. Reason: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor..

Recalling firm: Invivo Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-02-06
Terminated: 2022-05-04
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K023130 — ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEMMri Devices Corp.·cleared 2002-10-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.