Invivo Recalls Xper Flex Cardio PhysioMonitoring Systems Due to Communication Errors
Invivo Corporation is recalling 529 Xper Flex Cardio PhysioMonitoring systems because of intermittent communication issues between the host system and the device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Invivo Corporation is recalling 529 units of the Xper Flex Cardio PhysioMonitoring system, specifically Model 453564621791 and 453564621801, Revision C. The recall was initiated due to intermittent communication between the host system and the Flex Cardio device.
The Xper Flex Cardio PhysioMonitoring system is a medical device used by professional healthcare providers, including physicians and nurses, to facilitate invasive investigation of heart and vascular disease. The system displays and analyzes various physiological data, such as surface ECG, respiration, invasive pressure, and SpO2. The affected units were distributed worldwide, including in the United States and internationally to Germany, Hungary, India, the Netherlands, Russia, Saudi Arabia, South Africa, and Tunisia.
Healthcare providers and facilities using these devices should stop using the affected units and contact Invivo Corporation for further instructions on the recall process. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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 profe
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 529
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model 453564621791 and 453564621801 - ALL Flex Cardio Devices
- Revision C
Distribution
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