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.
Check against the official notice below — it lists the full affected range.
Invivo Corporation is recalling 2,929 Xper Flex Cardio Patient Monitoring System units (Models FC2010 and FC2020) that were distributed nationwide across all U.S. states, Washington DC, and multiple countries worldwide. The recalled devices may experience freezing of the display showing SpO2 (oxygen saturation) and Non-Invasive Blood Pressure (NIBP) measurements, which could affect the monitoring and viewing of patient data transmitted via intranet or Internet.
The recall affects specific serial numbers of the monitoring systems, which are identified in the recall record. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Reason for recall: Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze 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, Quantity: 2,929 Lot/code info: 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 USII08010061 USII08010051 USI319000034 USI319000071 USI311000015 USI203010326 US1203010289 US1109010105 USI337000014 USI234000065 USII08010062 USI319000046 USI324000021 USI2440000043 US1203010306 USI251000040 USI343000076 USI343000055 US 1337000010 US 1337000004 USI331000055 US 1319000070 USI319000042 US1311000051 USI251000073 USI239000036 USI234000060USI234000043 USI231000063 USI203010424 USI203010312 USI203010292 USI343000074 USI343000045 us 1343000040 us 1343000038 us 133 7000073 us 1337000069 USI337000
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.