FDAFDA · Food and drugs·Recall number Z-0827-2016
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Published March 2, 2016 · Recall initiated: February 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Draeger Medical, Inc.
- Distributor
- US Nationwide Distribution including Puerto Rico.
- Lot
- Catalog #s 8416400 and 8417400
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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