FDA Device recall Z-0870-2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Numb…
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Numb… 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-0870-2022 |
| 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
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Reason
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Identifiers
| code_info | All Lots/Serial Numbers. UDI: 04048675042266 |
|---|
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-0870-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.