Day

September 25, 2024
25
Sep

FDA Recall: Software Issue May Lead to Room Air Only Rather than HPO

September 25, 2024
Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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25
Sep

FDA Recall: Software Issue May Lead to Oxygen Desaturation

September 25, 2024
Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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