Michele Sleep Scoring System (2019-10-25)

Starting date:

October 25, 2019

Posting date:

January 31, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72213

Last updated: 2020-01-31

• Reason
• Affected products

Affected Products

Michele Sleep Scoring System

Reason

The affected software version fails to identify snoring events and the read-only file functionality was not working as intended. A new feature identifying bad heart-rate signal was not communicated to customers.

Affected products