FDAClass IIOctober 20, 2021

Babylog VN500 Ventilator with Installed CO2 Measurement recall: Software Issue

Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg…

Why was Babylog VN500 Ventilator with Installed CO2 Measurement recalled?

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Software 2.51 and Lower

Product
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg…
Recalling firm
Draeger Medical, Inc.
Quantity
2,169 units
Distribution
US Nationwide
Recall date
October 20, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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