FDA-Device2015-08-26Class I
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Draeger Medical, Inc.
Hazard
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Sold states
Nationwide Distribution.
Affected count
2081
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2343-2015Don't want to check this manually?
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