Product Wiki · Recalls · Health Canada — Medical Devices

Puritan Bennett 980 Series Ventilator -Ventilator (2018-09-20) — recall 58528

Health Canada — Medical Devices · Canada · 2018-11-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58528
Date of alert
2018-11-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Medtronic is issuing a Software update (Maintenance Release MR 5.4) to enhance the functionality of PB980 ventilators and correct the concerns raised by TGA (Australia's Therapeutic Goods Administration. The concerns raised by TGA surround External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/puritan-bennett-980-series-ven

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