PATIENT DATA MODULE (2021-06-14)

Starting date:

June 14, 2021

Posting date:

June 23, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75875

Last updated:
2021-06-23

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  Reason
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  Affected products

Affected Products 

PATIENT DATA MODULE

Reason

If the PDM with Masimo SET® technology has not been powered down completely in more than 2 years, it can display a frozen inaccurate SpO2 saturation value which no longer changes to reflect the patient’s clinical condition. This issue could result in missed SpO2 alarms and delayed diagnosis and treatment.

Affected products