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Published: 2016-03-02Captured: 2026-02-09Draeger Medical, Inc.Product: Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
FDA issued a Class I enforcement action. Affects Draeger Medical, Inc.. Reason: The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Ca.
- •Classification: Class I
- •Firm: Draeger Medical, Inc.
- •Status: Terminated
- •Distribution: US Nationwide Distribution including Puerto Rico.
Reason
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power ...
Status:Terminated
Distribution:US Nationwide Distribution including Puerto Rico.
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