MRI System Monitor (Invivo) – insufficient shielding (2020)
Computer monitor may have insufficient electromagnetic shielding.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Brand
Invivo Corporation
Lot Codes / Batch Numbers
9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Products Sold
9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Invivo Corporation is recalling Monitor for the Functional Imaging System for Magnetic Resonance Imaging System due to Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, CA, CO, FL, IL, IN, KY, MA, MI, NY, OH, OR, PA, TN, TX, WV
Page updated: Jan 10, 2026