Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Device Recall #Z-0462-2019 — Class II — September 24, 2018
Recall Summary
| Recall Number | Z-0462-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 24, 2018 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invivo Corporation |
| Location | Orlando, FL |
| Product Type | Devices |
| Quantity | 76 units |
Product Description
Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
Reason for Recall
The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard
Distribution Pattern
Distributed to the Netherlands
Lot / Code Information
Model Number 453564669081; System Serial Number (UDI): US1814000001 ((01)00884838091474(21)US1814000001), US1814000002 ((01)00884838091474(21)US1814000002), US1814000003 ((01)00884838091474(21)US1814000003), US1814000004 ((01)00884838091474(21)US1814000004), US1814000006 ((01)00884838091474(21)US1814000006), US1814000007 ((01)00884838091474(21)US1814000007), US1814000008 ((01)00884838091474(21)US1814000008), US1814000011 ((01)00884838091474(21)US1814000011), US1814000012 ((01)00884838091474(21)US1814000012), US1814000013 ((01)00884838091474(21)US1814000013), US1814000014 ((01)00884838091474(21)US1814000014), US1814000016 ((01)00884838091474(21)US1814000016), US1814000017 ((01)00884838091474(21)US1814000017), US1814000018 ((01)00884838091474(21)US1814000018), US1814000019 ((01)00884838091474(21)US1814000019), US1814000020 ((01)00884838091474(21)US1814000020), US1814000022 ((01)00884838091474(21)US1814000022), US1814000023 ((01)00884838091474(21)US1814000023), US1814000024 ((01)00884838091474(21)US1814000024), US1814000027 ((01)00884838091474(21)US1814000027), US1814000028 ((01)00884838091474(21)US1814000028), US1814000029 ((01)00884838091474(21)US1814000029), US1814000030 ((01)00884838091474(21)US1814000030), US1814000031 ((01)00884838091474(21)US1814000031), US1814000032 ((01)00884838091474(21)US1814000032), US1814000033 ((01)00884838091474(21)US1814000033), US1814000034 ((01)00884838091474(21)US1814000034), US1814000035 ((01)00884838091474(21)US1814000035), US1814000036 ((01)00884838091474(21)US1814000036), US1814000037 ((01)00884838091474(21)US1814000037), US1814000038 ((01)00884838091474(21)US1814000038), US1814000039 ((01)00884838091474(21)US1814000039), US1814000040 ((01)00884838091474(21)US1814000040), US1814000041 ((01)00884838091474(21)US1814000041), US1814000043 ((01)00884838091474(21)US1814000043), US1814000044 ((01)00884838091474(21)US1814000044), US1814000045 ((01)00884838091474(21)US1814000045), US1814000046 ((01)00884838091474(21)US1814000046), US1814000047 ((01)00884838091474(21)US1814000047), US1814000048 ((01)00884838091474(21)US1814000048), US1814000049 ((01)00884838091474(21)US1814000049), US1814000050 ((01)00884838091474(21)US1814000050), US1814000051 ((01)00884838091474(21)US1814000051), US1814000052 ((01)00884838091474(21)US1814000052), US1814000053 ((01)00884838091474(21)US1814000053), US1814000054 ((01)00884838091474(21)US1814000054), US1814000055 ((01)00884838091474(21)US1814000055), US1814000056 ((01)00884838091474(21)US1814000056), US1814000058 ((01)00884838091474(21)US1814000058), US1814000059 ((01)00884838091474(21)US1814000059), US1814000060 ((01)00884838091474(21)US1814000060), US1814000061 ((01)00884838091474(21)US1814000061), US1814000062 ((01)00884838091474(21)US1814000062), US1814000063 ((01)00884838091474(21)US1814000063), US1814000064 ((01)00884838091474(21)US1814000064), US1814000065 ((01)00884838091474(21)US1814000065), US1814000066 ((01)00884838091474(21)US1814000066), US1814000067 ((01)00884838091474(21)US1814000067), US1814000068 ((01)00884838091474(21)US1814000068), US1814000069 ((01)00884838091474(21)US1814000069), US1814000070 ((01)00884838091474(21)US1814000070), US1814000072 ((01)00884838091474(21)US1814000072), US1814000074 ((01)00884838091474(21)US1814000074), US1814000078 ((01)00884838091474(21)US1814000078), US1814000081 ((01)00884838091474(21)US1814000081), US1814000082 ((01)00884838091474(21)US1814000082), US1814000083 ((01)00884838091474(21)US1814000083), US1814000084 ((01)00884838091474(21)US1814000084), US1814000085 ((01)00884838091474(21)US1814000085), US1814000086 ((01)00884838091474(21)US1814000086), US1814000087 ((01)00884838091474(21)US1814000087), US1814000088 ((01)00884838091474(21)US1814000088), US1814000089 ((01)00884838091474(21)US1814000089), US1814000092 ((01)00884838091474(21)US1814000092), US1814000094 ((01)00884838091474(21)US1814000094), US1814000096 ((01)00884838091474(21)US1814000096),
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-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 |
| Z-1289-2018 | Class II | DynaCad software consist of an MR Analysis Serv... | Jan 24, 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.