FDAClass IIApril 13, 2022

Babylog VN500 Ventilator with Software 2.51.01 and recall

Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs)…

Why was Babylog VN500 Ventilator with Software 2.51.01 and recalled?

Cybersecurity Improvement Action-not equipped against potential cyber security threats

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?

All Lots/Serial Numbers. UDI: 04048675250418

Product
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs)…
Recalling firm
Draeger Medical, Inc.
Quantity
13,687 (2,987 units US)
Distribution
US Nationwide
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls