Z-1440-2020Class II

Monitor for the Functional Imaging System for Magnetic Resonance Imaging System

Name: Z-1440-2020 Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Creator: Invivo Corporation
Published: 2020-02-06
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2020-02-06 / Terminated

FDA source

Invivo Corporation began a recall of Monitor for the Functional Imaging System for Magnetic Resonance Imaging System on 2020-02-06. FDA classified it as Class II and gives the reason as "Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1440-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-06
Posted: 2020-03-04
Terminated: 2022-05-04
Recalling firm: Invivo Corporation
Product: Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
FDA root cause: Component change control
Action: On February 5, 2020 Invivo sent out URGENT Field Safety Notice identifying problem and under what circumstances it can occur; the actions that should be taken by the customer / user in order to prevent risks for patients or users and the actions planned by Philips to correct the problem. PRODUCTS Products manufactured between O8DEC2O1S and 09MAY2019 are in scope of this field correction and can be identified by the manufacturing date printed in the SensaVue Cart label. ACTION TO BE TAKEN BY CUSTOMER/ USER: Although the level of emissions is undetectable without specialized equipment and pose no risk to user or patient safety, customers shall contact their service provider. Customers can request Part Number 459801750971 PACKAGE. FCD SensaVue DVI Adapter to obtain a new, compliant DVI adapters. Please follow the instructions in the kit to replace two (2) adapters in the back of the operator computer. After replacement, complete and e-mail the Action Notification Report included in the kit and discard the old adapters. ACTIONS PLANNED BY PHILIPS A replacement DVI adapter has been selected, tested and passed the requirements for emissions contained within IEC 60601-1-2 3rd/4th edition. This new DVI adapter will be used to replace non-compliant DVI adapters in the field shipped from 06DEC2018 to 09MAY2019. FURTHER INFORMATION AND SUPPORT If you need any further information or support concerning this issue, please contact your local Philips representative: North America: 1-877-Invivo-1 option 3
Quantity in commerce: 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.
Product codes and lots: 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1440-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1440-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code LNH

K023130Class IIEloquence, Integrated Functional Imaging SystemMri Devices Corp. / cleared 2002-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)