Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
This recall has been terminated (originally issued February 6, 2020).
- Company
- Invivo Corporation
- Recall Initiated
- February 6, 2020
- Terminated
- May 4, 2022
- Recall Number
- Z-1440-2020
- Quantity
- 75
- Firm Location
- Gainesville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
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.
Lot / Code Info
9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Root Cause
Component change control
Action Taken
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