Xper Flex Cardio Physiomonitoring System Model # 453564669081… — Class II medical device recall Z-3192-2018
Terminated recall by Invivo Corporation, reported 2018-09-26. Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitorin
| Recall number | Z-3192-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invivo Corporation, Orlando, FL, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2021-07-15 |
| Countries outside the US | NL |
| Quantity | 38 |
| Reason classes | software |
| Serial numbers | US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US1814000008, US1814000011, US1814000012, US1814000013, US1814000014, US1814000016, US1814000017, US1814000018, US1814000019, US1814000020, US1814000022, US1814000023, US1814000024, US1814000027, US1814000028, US1814000030, US1814000031, US1814000032, US1814000033 and 10 more |
| Model numbers | 453564669081 |
Product
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Reason for recall
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault.
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-3192-2018. 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.