Recall Z-1440-2020 ยท LNH System, Nuclear Magnetic Resonance Imaging
Invivo Corporation
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
| Date | Feb 6, 2020 |
| Status | Terminated |
| Reason | Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. |
| 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 po |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM Mri Devices Corp., Oct 11, 2002 |