FDA Device recall Z-3192-2018
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 by Invivo, citing 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 inac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3192-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-03 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Invivo |
| Distribution | n/a |
Product
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Reason
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.
Identifiers
| code_info | System Serial Numbers: US1814000001, US1814000002, US1814000003, US1814000004, US1814000006, US1814000007, US181400000…System 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, US1814000034, US1814000037, US1814000044, US1814000046, US1814000050, US1814000053, US1814000062, US1814000066, US1814000068,and US1814000072 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3192-2018%22
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