Class 2 Device Recall SensaVue Patient Entertainment System

• Date Initiated by Firm: February 06, 2020
• Create Date: March 04, 2020
• Recall Status: Terminated on May 04, 2022
• Recall Number: Z-1440-2020
• Recall Event ID: 84957
• 510(K)Number: K023130
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
• Code Information: 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
• Recalling Firm/ Manufacturer: Invivo Corporation; 3545 SW 47th Ave; Gainesville FL 32608-7691
• For Additional Information Contact: Kenneth Revennaugh; 352-336-0010
• Manufacturer Reason for Recall: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LNH