FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Medtronic Issues Corrective Action for Puritan Bennett 980 Ventilator

Dec. 21, 2018

Medtronic has put out a voluntary field corrective action for its Puritan Bennett 980 ventilator, a prescription device that helps support a patient’s breathing.

The prescription device — which is used by trained healthcare professionals in clinical settings for neonatal, pediatric and adult patients — is receiving a software update to address consumer feedback, the FDA said.

The software update patches the device’s external USB drive performance and its impact on GUI functionality and labeling displayed on the interface during device use. All PB980 ventilators are being updated to the new software version at customer facilities.

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