FDA Device recall Z-0871-2022
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…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of 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… by Draeger Medical, citing cybersecurity Improvement Action-not equipped against potential cyber security threats.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0871-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-14 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Draeger Medical |
| Distribution | US |
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) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight Catalog Number: 8417400
Reason
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Identifiers
| code_info | All Lots/Serial Numbers. UDI: 04048675250418 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0871-2022%22
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