Draeger Medical, Inc. recalls PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and…
- Recall date
- July 13, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2343-2015
- FDA classification
- Class I
- Brand / firm
- Draeger Medical, Inc.
- Sold / distributed
- Nationwide Distribution.
Why it was recalled
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Get recall alerts
Free email alert whenever Draeger Medical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Draeger Medical, Inc.