FDA-Device2015-01-21Class II
Philips Expression MR200 MRI Patient Monitoring System.
Invivo Corporation
Hazard
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
Sold states
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.
Affected count
20
Manufactured in
12151 Research Pkwy, Suite 200, Orlando, FL, United States
Products
Philips Expression MR200 MRI Patient Monitoring System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2015Don't want to check this manually?
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