Reported Mar 2, 2016 · Terminated
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Draeger Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
- Lot codes and dates
- Catalog #s 8416400 and 8417400
- Amount recalled
- 2553
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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