Reported Jun 13, 2018 · Ongoing
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive…
Invivo Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Invivo Corporation · 12151 Research Pkwy Ste 200 · Orlando, FL · 32826-3286
Is this the product you have?
- 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.
- Lot codes and dates
- MODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801)
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- Amount recalled
- 1,040 units (USA) and 7 units (Foreign)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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