FDA-Device2016-09-14Class II

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.

Invivo Corporation
Hazard

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

Sold states
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.
Affected count
2,929
Manufactured in
12151 Research Pkwy Ste 200, Orlando, FL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2760-2016

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief