Xper Flex Cardio Physiomonitoring System — Class II medical device recall Z-0614-2019
Terminated recall by Philips Electronics North America Corporation, reported 2018-12-26. There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displaye
| Recall number | Z-0614-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corporation, Andover, MA, United States |
| Recall initiated | 2018-11-15 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2024-09-20 |
| Quantity | 651 units |
| Model numbers | 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 |
Product
Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
Reason for recall
There are 3 issues: 1) Under certain conditions, real time waveforms may not be accurately plotted or displayed. 2) The oxygen saturation (SpO2) numeric value displayed on the device may freeze. 3) In auto cycle mode, if the NIBP communication is lost, the pump would not cycle and the non-invasive blood pressure (NIBP) numeric value displayed on the device would not update.
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-0614-2019. 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.