FDA Device recall Z-2343-2015
PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
- FDA Device
- Class I
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class I recall of PS500 of an IACS Workstation Critical Care (Evita Infinity V500) by Draeger Medical, citing the battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2343-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-07-13 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Reason
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Identifiers
| code_info | Catalog Number(s): 8416400, 8417400 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2015%22
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