PS500 of an IACS Workstation Critical Care — Class I medical device recall Z-2343-2015
Terminated recall by Draeger Medical, Inc., reported 2015-08-26, distributed nationwide. The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not
| Recall number | Z-2343-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2015-07-13 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2017-03-01 |
| Distributed | Nationwide (US) |
| Quantity | 2,081 |
| Model numbers | 8416400, 8417400, PS500 |
Product
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Reason for recall
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
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-2343-2015. 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.