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PATIENT DATA MODULE (2021-06-14) — recall 62541

Health Canada — Medical Devices · Canada · 2021-06-23 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 62541
Date of alert: 2021-06-23
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Medical devices
Product type: Medical devices

Reported risk: If the PDM with Masimo SETÂ® 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.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/patient-data-module-2021-06-14

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PATIENT DATA MODULE (2021-06-14) — recall 62541

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