FDA Device recall Z-2115-2018
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart…
- FDA Device
- Class II
- ongoing
- Published 2018-06-13
On 2018-06-13 the FDA classified a Class II recall of Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart… by Invivo, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2115-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-11-20 |
| Published | 2018-06-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | US |
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. 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.
Reason
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.
Identifiers
| code_info | MODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453…MODEL #(s): 453564428541 (Service # 453564241911), 453564243601 (Service # 453564483331), 453564634211 (Service # 453564621801) SERIAL NUMBERS: US1203010251, US1239000027, US1203010279, US1203010280, US1203010308, US1203010334, US1203010346, US1203010352, US1203010358, US1203010360, US1203010366, US1203010375, US1203010398, US1203010407, US1304000043, US1304000046, US1224000050, US1550001470, US1251000063, US1109010070, US1109010072, US1109010075, US1201010130, US1331000013, US1505000507, US1343000034, US1311000042, US1337000033, US1201010112, US1201010119, US1201010120, US1201010122, US1202010171, US1202010186, US1202010202, US1203010396, US1231000007, US1231000032, US1231000050, US1231000074, US1231000090, US1234000008, US1311000016, US1311000023, US1248000071, US1708000101, US1720000441, US1550001478, US1248000065, US1729000603, US1352000006, US1352000022, US1352000044, US1352000046, US1352000048, US1107010005, US1231000060, US1537001268, US1537001272, US153700 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Other recalls by Invivo
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FDA Device · Class III · 2020-10-28 · Invivo - Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
FDA Device · Class II · 2020-03-11 · Invivo - Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Device · Class II · 2018-11-21 · Invivo - Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
FDA Device · Class II · 2018-09-26 · Invivo - PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international…
FDA Device · Class II · 2018-05-23 · Invivo
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2115-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.