The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2751-2018·Announced 2018-08-22

Terumo CDI System 500 Monitor Recalled for H/Sat Module Self-Test Failure

Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source explicitly states that the issue 'will not result in device inaccuracy,' only disabling a specific module. This aligns with the rubric for moderate severity, representing a functional limitation or precautionary recall without reported harm or inaccuracy.

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 128 units of the CDI System 500 monitor, specifically the 500AHCT and 500AVHCT models. These devices provide continuous, on-line monitoring of extracorporeal blood parameters, including oxygen and carbon dioxide partial pressure, pH, potassium, oxygen saturation, hematocrit, hemoglobin, and temperature.

The recall is due to a hybrid intensity shift observed in a subset of the H/Sat population. This shift causes the devices to fail the H/Sat Color Chip Test, which is an automated self-test performed when the device is powered on. According to the source text, this failure disables the H/Sat module but does not result in device inaccuracy for the other monitored parameters.

The affected units were distributed worldwide, including nationwide in the United States and to regions in the Middle East, Latin America, Europe, Japan, Canada, and Mexico. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

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…
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Patient Monitor
Hazard
Affected units
128

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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