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. 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.
Enforcement
- Recall Number
- Z-2115-2018
- Event ID
- 80057
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Invivo Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 13, 2018
- Initiation Date
- November 20, 2017
- Classification Date
- June 7, 2018
- Address
- 12151 Research Pkwy Ste 200, N/A, Orlando, FL, 32826-3286, United States
Description
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. 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.
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
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Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.
1,040 units (USA) and 7 units (Foreign)