Invivo Corporation: Medical Device Recall in 2018 - (Recall #: Z-3192-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388

Product Classification:

Class II

Date Initiated: August 3, 2018

Date Posted: September 26, 2018

Recall Number: Z-3192-2018

Event ID: 80761

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.

Status: Terminated

Product Quantity: 38

Code Information:

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

Distribution Pattern:

Distribution in the Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated