# FDA recall Z-2751-2018

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-06-26.

## Product

Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT  Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT    Product Usage:  The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

## Reason for recall

H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip Test Failure which disables the H/Sat module.

## Distribution

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, SC, TN, TX, WA, and WV. Foreign distribution to Middle East, Latin America, Europe, Japan, Canada, and Mexico.

## Key facts

- **Recall number:** Z-2751-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-26
- **Report date:** 2018-08-22
- **Termination date:** 2020-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2751-2018

## Citation

> AI Analytics. FDA recall Z-2751-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2751-2018. Source: US FDA. Licensed CC0.

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