# FDA recall Z-3192-2018

> **Invivo Corporation** · Class II · device recall initiated 2018-08-03.

## 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.

## Distribution

Distribution in the Netherlands

## Key facts

- **Recall number:** Z-3192-2018
- **Recalling firm:** Invivo Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-03
- **Report date:** 2018-09-26
- **Termination date:** 2021-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3192-2018

## Citation

> AI Analytics. FDA recall Z-3192-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-3192-2018. Source: US FDA. Licensed CC0.

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