FDA-Device2015-08-05Class II
Invivo Expression MRI Patient Monitoring System.
Philips Electronics North America Corporation
Hazard
The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.
Sold states
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OR, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Alaska, Hawaii and the District of Columbia, and the countries of Argentina, Australia, Austria, Canada, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, Iceland, Israel, Italy, Japan, Netherlands, Norway, Oman, Poland, Portugal, Russian Federation, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, United Arab Emirates, and United Kingdom.
Affected count
697 devices.
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Invivo Expression MRI Patient Monitoring System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2266-2015Don't want to check this manually?
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