Evita Infinity V500 Ventilator — Class I medical device recall Z-0827-2016
Terminated recall by Draeger Medical, Inc., reported 2016-03-02, distributed nationwide. The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and N
| Recall number | Z-0827-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2016-02-04 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2020-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,553 |
| Reason classes | software |
| Model numbers | 8416400, 8417400 |
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Reason for recall
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
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-0827-2016. 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.