PHILIPS Xper Flex Cardio Physiomonitoring System — Class II medical device recall Z-1867-2018
Terminated recall by Invivo Corporation, reported 2018-05-23, distributed nationwide. The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be
| Recall number | Z-1867-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2018-03-14 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2021-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BG, CA, CH, CL, CN, CY, DE, EG, ES, FI, FR, GB, GR, HU, ID, IE, IN, IR, IT, KE, KR, MX, MY, NL, NZ, PH, PK, PL, RO, SA, SE, SG, TH, TN, TR, TW, VN, ZA |
| Quantity | 4,375 units |
| UPC / GTIN / UDI-DI | 00884838082113, 00884838083523, 00884838083530, 00884838084902, 00884838084926, 00884838084933 |
| Model numbers | 453564241901, 453564483321, 453564621791, 989803199561 |
Product
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) 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.
Reason for recall
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
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-1867-2018. 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.