Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio… — Class II medical device recall Z-2115-2018
Ongoing recall by Invivo Corporation, reported 2018-06-13, distributed nationwide. While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the
| Recall number | Z-2115-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2017-11-20 |
| Classified | 2018-06-07 |
| Reported by FDA | 2018-06-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, GB, KR |
| Serial numbers | US1107010000, US1107010004, US1107010005, US1107010009, US1107010013, US1107010014, US1107010018, US1107010028, US1107010029, US1107010032, US1107010034, US1107010035, US1107010039, US1108010043, US1108010044, US1108010045, US1108010048, US1108010052, US1108010057, US1108010060, US1109010069, US1109010070, US1109010072, US1109010073, US1109010075 and 475 more |
| Model numbers | 453564243601, 453564428541, 453564634211 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2115-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.