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

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.

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All Invivo recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3192-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.