Severe FDA (Devices)·Z-0827-2016·Announced 2016-03-02

Draeger Medical Recalls Evita and Babylog Ventilators Due to Battery Defect

Draeger Medical is recalling Evita Infinity V500 and Babylog Infinity VN500 ventilators because the optional PS500 power supply unit batteries may discharge prematurely despite showing adequate charge.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe). The defect involves critical medical equipment where unexpected battery discharge could lead to significant harm.

Plain-English summary

Draeger Medical, Inc. is recalling 2,553 units of the Evita Infinity V500 Ventilator and Babylog Infinity VN500 Ventilator. The recall involves the optional PS500 power supply unit used with the Infinity (ACS) Workstation for Critical and Neonatal Care. The affected units were distributed nationwide in the United States, including Puerto Rico.

The recall is due to a defect where the battery capacity of the optional PS500 power supply unit rapidly and unexpectedly reduced. This issue occurred even when the device was using the most recent power supply firmware version 1.50, released in November 2015. The batteries were found to be prematurely discharged, even though the device displayed an adequate battery charge status.

Healthcare facilities and users of these ventilators should contact Draeger Medical, Inc. for further instructions on how to address the battery defect. The recall number is Z-0827-2016.

The recalled product

Product: Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Manufacturer: Draeger Medical, Inc.
Category: Medical Device — Ventilators
Hazard: battery-defect
power-loss
Affected units: 2,553

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)

Catalog #s 8416400 and 8417400

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Draeger Medical, Inc.

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