CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly (2018-10-10)

Starting date:

October 10, 2018

Posting date:

November 15, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68224

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  Reason
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  Affected products

Affected products

CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly

Reason

A specific subset of the h/sat probe assembly population is being withdrawn due to a supplied component in the optics, the optical module. A change by the supplier to a different material and anodization resulted in increased failures. The CDI System 500 monitor conducts an automated self-test when the device is powered on. If the monitor contains an affected component, a color chip test failure will occur and the h/sat probe will be disabled.

Affected products