Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Reported: March 2, 2016 Initiated: February 4, 2016 #Z-0827-2016
Product Description
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Reason for Recall
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.
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 2553
- Distribution
- US Nationwide Distribution including Puerto Rico.
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.. Recalled by Draeger Medical, Inc.. Units affected: 2553.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2016. Severity: Critical. Recall number: Z-0827-2016.
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