# FDA recall Z-2115-2018

> **Invivo Corporation** · Class II · device recall initiated 2017-11-20.

## Product

Xper Flex Cardio Physiomonitoring System    The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such.  The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves.

## Reason for recall

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## Distribution

Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NM, NY, NV, OH, PA, RI, SC, TN, TX, VA, WA, and WI ; and countries of: Canada, China, Great Britain and Korea.

## Key facts

- **Recall number:** Z-2115-2018
- **Recalling firm:** Invivo Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-11-20
- **Report date:** 2018-06-13

- **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-2115-2018

## Citation

> AI Analytics. FDA recall Z-2115-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-2115-2018. Source: US FDA. Licensed CC0.

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