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Lower risk Medical device recall · FDA · Published August 3, 2018

Invivo Xper Flex Cardio Monitor Software Issue: Intermittent ECG Errors

Invivo recalls Xper Flex Cardio Physiomonitoring System with faulty software version 1.6.0.0388 that may cause inaccurate ECG readings and heart rate displays. Affected units have specific serial numbers listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3192-2018Medical deviceInvivo ›
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Contact the company

Recalling firmInvivo Corporation12151 Research Pkwy Ste 200 · Orlando, FL 32826-3286
✎ GovInfoNow plain-language explainer

Invivo is recalling a specific software version of their Xper Flex Cardio Physiomonitoring System due to potential inaccuracies in ECG monitoring and heart rate readings. This could lead to incorrect medical assessments if the device is used for patient monitoring. Read more at govinfonow.com/recall/70190-invivo-xper-flex-cardio-monitor-software-issue-intermittent-ecg-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/70190-invivo-xper-flex-cardio-monitor-software-issue-intermittent-ecg-errors · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3192-2018

Cite this page

“Invivo Xper Flex Cardio Monitor Software Issue: Intermittent ECG Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70190-invivo-xper-flex-cardio-monitor-software-issue-intermittent-ecg-errors. Based on FDA recall #Z-3192-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3192-2018%22&limit=1).

The FDA announced on 2018-08-03 that Invivo Corporation is recalling the Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 due to an incorrect firmware version. The hazard includes intermittent loss of ECG monitoring and inaccurate heart rate displays.

How to tell if you have it

  • Brand: Invivo
  • Product: Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
  • 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
  • Units affected: 38
  • Distribution: Netherlands

The hazard

The devices were released with an incorrect, older firmware version installed. This may result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate displayed due to QRS detection fault.

Context

GovInfoNow's records show Invivo Corporation has 8 other recalls on record since 2017-08-11. Other recent recalls of similar products include Midmark IQecg ECG Software Error: Incorrect Heart Rate Readings (2026-07-20), Midmark ECG Devices May Show Incorrect Heart Rhythm Readings (2026-07-20), and Philips Cardiac Workstation 5000: Inaccurate Heart Rate Data Risk (2026-07-01).

How to tell if you have this one

Check if your Xper Flex Cardio Physiomonitoring System has software version 1.6.0.0388 and one of the listed serial numbers: US1814000001 through US1814000072.

  • Brand
    Invivo
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software Version

    Contact Invivo Corporation to update to the corrected software version 1.6.0.0388 or later.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Aug 3, 201812. FDA classified it Class II: Sep 18, 201823. Published in FDA’s Enforcement Report: Sep 26, 201834. FDA terminated the recall: Jul 15, 2021420182021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3192-2018 (August 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3192-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA