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Recall Observatory FDA recall evidence

Device 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 professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status.

Z-0082-2018

August 11, 2017

Class II

Product summary

Firm
Invivo Corporation
Event
Event 78465
Status
Terminated
Classification
Class II
Quantity
529
Official record key
device-enforcement:Z-0082-2018

Official wording

Reason: Intermittent communication between the host system and the Flex Cardio

Code information: Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Intermittent communication between the host system and the Flex Cardio