Invivo Corporation recalls The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locatio…

Recall date

October 19, 2015

Source

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

Recall number

Z-2760-2016

FDA classification

Class II

Brand / firm

Invivo Corporation

Sold / distributed

Nationwide Distribution to the states of :AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, TN, UT, VA, WA, WI, WV, Alaska, Hawaii, & Washington, DC. Worldwide Distribution to the countries…

Why it was recalled

Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze

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

What was recalled

The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.