FDA Device recall Z-0827-2016
Evita Infinity V500 Ventilator
- FDA Device
- Class I
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class I recall of Evita Infinity V500 Ventilator by Draeger Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0827-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-02-04 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
Reason
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.
Identifiers
| code_info | Catalog #s 8416400 and 8417400 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0827-2016%22
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