FDAClass IIMarch 11, 2020

Monitor for the Functional Imaging System for Magnetic recall

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Why was Monitor for the Functional Imaging System for Magnetic recalled?

Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Recalling firm
Invivo Corporation
Quantity
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.
Recall date
March 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls