Primary source: What is an Early Alert?
The FDA clarified the reason for the recall and communicated that it is classified as a Class II Recall regarding the use of GE HealthCare's Portrait Core Services software. This includes providing updated use instructions for ensuring patient monitoring safety.
Failure to follow the updated use instructions may lead to a loss of patient monitoring capability or incorrect alarm notifications, which could potentially result in reversibly harmful health outcomes.
Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.
The FDA has classified the issue as a Class II Recall after determining that the Portrait Core Services software updates could lead to patient discharges from monitoring and incorrect alarm settings. Facilities must implement alternative monitoring methods prior to updates.
What changed: The FDA clarified the reason for the recall and communicated that it is classified as a Class II Recall regarding the use of GE HealthCare's Portrait Core Services software. This includes providing updated use instructions for ensuring patient monitoring safety.
Why it matters: Failure to follow the updated use instructions may lead to a loss of patient monitoring capability or incorrect alarm notifications, which could potentially result in reversibly harmful health outcomes.
Practical implication: Facilities must ensure that appropriate alternative monitoring is established for patients before performing software updates and include the User Manual addendum with the equipment.
Published from the regulator source ingestion pipeline after PV impact triage.
Users must carefully inspect the VentStar Resus Neo hoses for damages as per the product's Instructions for Use (IFU) and discard any hoses showing signs of cracks or detachments before use.
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