Product Wiki · Recalls · Health Canada — Medical Devices

Prodigy Sleep System HMU & CMU (2020-04-08) — recall 63379

Health Canada — Medical Devices · Canada · 2020-05-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63379
Date of alert
2020-05-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: TTU software is unable to process audio samples fast enough and samples are dropped instead of buffered. This leads to missing samples, with no way to reconstruct the original audio signal. This can lead to underreporting of snoring events in a sleep study
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/prodigy-sleep-system-hmu-cmu-2

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