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.
Reported: September 14, 2016 Initiated: October 19, 2015 #Z-2760-2016
Product Description
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.
Reason for Recall
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Details
- Recalling Firm
- Invivo Corporation
- Units Affected
- 2,929
- Distribution
- 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.
- Location
- Orlando, FL
Frequently Asked Questions
What product 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.. Recalled by Invivo Corporation. Units affected: 2,929.
Why was this product recalled? ▼
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2016. Severity: Moderate. Recall number: Z-2760-2016.
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