Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display
Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that monitors vital signs, which fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Invivo Corporation is recalling the Xper Flex Cardio Patient Monitoring System, models FC2010 and FC2020. The recall involves 2,929 units that were distributed nationwide and worldwide.
The FDA has classified this as a Class II recall because the system's display of SpO2 (oxygen saturation) and Non-Invasive Blood Pressure (NIBP) measurements may freeze. This defect could result in the loss of patient data or inaccurate readings, posing a risk of harm to patients.
Healthcare facilities and users should contact Invivo Corporation for instructions on how to resolve the issue. The affected serial numbers are listed in the official recall documentation.
The recalled product
- Product
- 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.
- Manufacturer
- Invivo Corporation
- Hazard
- Affected units
- 2,929
Distribution
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