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) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Reported: April 13, 2022 Initiated: February 14, 2022 #Z-0871-2022
Product Description
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) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Reason for Recall
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 13,687 (2,987 units US)
- Distribution
- US Nationwide
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
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) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400. Recalled by Draeger Medical, Inc.. Units affected: 13,687 (2,987 units US).
Why was this product recalled? ▼
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0871-2022.
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