Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care pr
Check against the official notice below — it lists the full affected range.
The Xper Flex Cardio physiomonitoring system, manufactured by Invivo Corporation, is a medical device used to help doctors investigate heart and vascular disease during invasive procedures. The company is recalling 529 units of this device worldwide, including units distributed across the United States and internationally to countries including Germany, Hungary, India, the Netherlands, Russia, Saudi Arabia, South Africa, and Tunisia. The recalled devices are Model 453564621791 and 453564621801, Revision C.
The recall was initiated due to intermittent communication problems between the host system and the Flex Cardio device. The source record does not specify a remedy or describe what consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Intermittent communication between the host system and the Flex Cardio
Reason for recall: Intermittent communication between the host system and the Flex Cardio Distribution: Worldwide Distribution - US including AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KY, LA, MA, MI, MO, NC, NE, NM, NY, OH, OR, OK, PA, SD, TN, TX, VA, WA, WV and Internationally to Germany, Hungary, India, Netherlands, Russia, Saudi Arabia, South Africa and Tunisia. Quantity: 529 Lot/code info: Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.