Device product
Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
Z-1440-2020
Product summary
- Event
- Event 84957
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75
- Official record key
device-enforcement:Z-1440-2020
Official wording
Reason: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Code information: 9896-032-0815 SensaVue HD and 9896-032-0872x SensaVue fMRI
Distribution pattern: 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.
Derived failure modes
-
Unknown
Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.