Evita V500 Ventilator with Installed CO2 Measurement Option-Intended… — Class II medical device recall Z-0108-2022
Ongoing recall by Draeger Medical, Inc., reported 2021-10-20, distributed nationwide. Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief
| Recall number | Z-0108-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2021-09-10 |
| Classified | 2021-10-13 |
| Reported by FDA | 2021-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 6,797 units |
| Reason classes | software |
| Model numbers | 8416400 |
Product
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Reason for recall
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
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-0108-2022. 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.