Puritan Bennett 980 Ventilator Recalled for Occasional GUI Resets
Covidien is voluntarily recalling 418 Puritan Bennett 980 ventilators due to occasional graphical user interface resets lasting approximately 30 seconds.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary action for a software glitch (GUI reset) with no reported injuries or illnesses in the source text.
Plain-English summary
Covidien LP is issuing a voluntary field action for all Puritan Bennett 980 ventilators. The recall involves 418 units that were distributed nationwide in the United States and internationally to Canada.
The action is being taken due to occasional graphical user interface (GUI) transient resets that last approximately 30 seconds. The Puritan Bennett 980 Ventilator System is designed for use on neonatal through adult patient populations who require respiratory support or mechanical ventilation.
Consumers and healthcare facilities should contact the manufacturer for further instructions regarding the field action.
The recalled product
- Product
- Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum
- Category
- Medical Device — Ventilator
- Hazard
- Affected units
- 418
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Puritan Bennett 980 ventilators
Distribution
Distributed nationwide across the United States.
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