Xper Flex Cardio Physiomonitoring System — Class II medical device recall Z-0462-2019
Completed recall by Invivo Corporation, reported 2018-11-21. The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following function
| Recall number | Z-0462-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2018-09-24 |
| Classified | 2018-11-14 |
| Reported by FDA | 2018-11-21 |
| Countries outside the US | NL |
| Quantity | 76 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884838091474 |
| Serial numbers | US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000029, US1814000030, US1814000031, US1814000032 and 51 more |
| Model numbers | 453564669081 |
Product
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
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-0462-2019. 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.