FDA-Device2014-08-27Class II
Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
Invivo Corporation
Hazard
The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
Sold states
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii, Alaska, and District of Columbia; and countries of: Australia, Austria, Denmark, France, Germany, Ireland, Netherlands, Norway, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Affected count
573 devices.
Manufactured in
12151 Research Pkwy, Suite 200, Orlando, FL, United States
Products
Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2270-2014Don't want to check this manually?
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