Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such.
Check against the official notice below — it lists the full affected range.
Invivo Corporation is recalling the Xper Flex Cardio Physiomonitoring system, a device used to help doctors investigate heart and vascular disease. The recall affects 4,535 devices distributed across the United States, Puerto Rico, and multiple international locations. The devices being recalled are all Flex Cardio devices in Revision A and B with specific code numbers, and the reason for the recall is intermittent communication between the host system and the FlexCardio device.
The recall record does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Intermittent communication between the host system and the FlexCardio
Reason for recall: Intermittent communication between the host system and the FlexCardio Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Puerto Rico Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bulgaria, Cambodia, Canada, Cayman Island, Chile, China, Colombia, Congo, Cote D'Ivoire, Cuba, Cyprus, Denmark, Dominican R Quantity: 4,535 Lot/code info: All Flex Cardio devices, Revision A, B Code Number's: 453564241901, 453564241911, 453564483321, 453564483331, 989803185601, 9898031930191, 860335 and 860338
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.