Critical Care Ventilator — Class II medical device recall Z-1690-2021
Terminated recall by Draeger Medical, Inc., reported 2021-06-09, distributed nationwide. Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog V
| Recall number | Z-1690-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2021-04-16 |
| Classified | 2021-05-28 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2024-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 34 units |
| Reason classes | software |
| Model numbers | 8422300 |
Product
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason for recall
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
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-1690-2021. 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.