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CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly… — recall 58475

Health Canada — Medical Devices · Canada · 2018-11-15 · Type III

As described by Health Canada — Medical Devices: CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly (2018-10-10)

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Agency
Health Canada — Medical Devices
Recall identifier
58475
Date of alert
2018-11-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A specific subset of the h/sat probe assembly population is being withdrawn due to a supplied component in the optics, the optical module.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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cdi-blood-parameter-monitoring

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