Z-2760-2016 Class II Terminated
FDA device recall Z-2760-2016 was initiated by Invivo Corporation on October 19, 2015 and is designated Class II. Reason for recall: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze The recall status is terminated (terminated October 4, 2019). Affected quantity: 2,929.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- October 19, 2015
- Termination Date
- October 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,929
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
Distribution Pattern
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.
Code Information
Product: Xper Flex Cardio Patient Monitoring System Model Numbers FC2010 and FC2020 Serial Numbers by Product: 453564241901 USI203010414 USI244000011 USI234000052 USI521000021 USI343000067 USI343000030 USI337000084 USI334000030 USI331000048 US 1328000004 USI324000049 USI324000017 USI319000088 US1319000043 USI319000016 USI251000082 USI251000054 USI251000042 USI251000007 USI25000054 USI248000041 USI234000090 USI224000028 USI203010318 USI202010188 USI343000053 USI251000005 USI231000001 US1334000034 USI334000018 USI319000053 USI234000045 us 1343000064 us 1343000018 us 1334000026 us 1334000008 USI324000025 USI311000001 USI239000005 USI234000054 USI224000026 USI203010419 USI203010418 USI203010411 USI203010403 USI203010391 US1203010372 USI203010301 US120301 0256 USI20201 0209 USII0701 0022 USI343000015 USI334000028 USI319000077 USI337000059 US1337000022 USI33!000014 USI319000087 USI319000061 US1319000002 USI244000002 USI239000049 USI203010392 USI203010264 US1201010131 USI109010102 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