Evita Infinity V500 Ventilator recall
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Why was Evita Infinity V500 Ventilator 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog #s 8416400 and 8417400
- Product
- Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
- Recalling firm
- Draeger Medical, Inc.
- Quantity
- 2553
- Distribution
- US Nationwide Distribution including Puerto Rico.
- Recall date
- March 2, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)