Philips Electronics North America Corporation recalls Invivo Expression MRI Patient Monitoring System.

Recall date

June 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2266-2015

FDA classification

Class II

Brand / firm

Philips Electronics North America Corporation

Sold / distributed

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 Ar…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Invivo Expression MRI Patient Monitoring System.