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Invivo Corporation recalls The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed location
Recalled September 14, 2016 · FDA recall Z-2760-2016 · Invivo
Hazard
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze · FDA Class II
Units
2,929
Sold at
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 of : Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Cayman Islands, Chile, Columbia, Croatia, Democratic Republic of Congo, Denmark, Ecuador, Egypt, Estonia, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jordan, Kazakhstan, Republic of Korea, Lebanon, Libya, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, State of Palestine, Panama, Papua New Guinea, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Taiwan Province, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United Republic of Tanzania, Uzbekistan, & Vietnam.
Description
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Product
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.
Manufacturer(s)
Invivo Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →