Evita V500 Ventilator with Software 2 — Class II medical device recall Z-0870-2022
Terminated recall by Draeger Medical, Inc., reported 2022-04-13, distributed nationwide. Cybersecurity Improvement Action-not equipped against potential cyber security threats
| Recall number | Z-0870-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2022-02-14 |
| Classified | 2022-04-04 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2025-01-07 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04048675042266 |
| Serial numbers | 04048675042266 |
| Model numbers | 8416400 |
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 for recall
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0870-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.