Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used t...
FDA Device Recall #Z-0082-2018 — Class II — August 11, 2017
Recall Summary
| Recall Number | Z-0082-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 11, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invivo Corporation |
| Location | Orlando, FL |
| Product Type | Devices |
| Quantity | 529 |
Product 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. 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.
Reason for Recall
Intermittent communication between the host system and the Flex Cardio
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.
Lot / Code Information
Model 453564621791 and 453564621801 - ALL Flex Cardio Devices, Revision C
Other Recalls from Invivo Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0126-2021 | Class III | MR Coils The MR Coil is intended to be used ... | Sep 14, 2020 |
| Z-1440-2020 | Class II | Monitor for the Functional Imaging System for M... | Feb 6, 2020 |
| Z-0462-2019 | Class II | Xper Flex Cardio Physiomonitoring System, Softw... | Sep 24, 2018 |
| Z-3192-2018 | Class II | Xper Flex Cardio Physiomonitoring System Model ... | Aug 3, 2018 |
| Z-1867-2018 | Class II | PHILIPS Xper Flex Cardio Physiomonitoring Syste... | Mar 14, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.