FDA-Device2016-09-28Class II
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Invivo Corporation
Hazard
Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Sold states
Worldwide distribution. US nationwide, Australia, Austria, Denmark, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and England
Affected count
639 units
Manufactured in
12151 Research Pkwy Ste 200, Orlando, FL, United States
Products
Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2867-2016Don't want to check this manually?
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