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Devices
Device Recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
Model / Serial
Catalog Number(s): 8416400, 8417400
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
Manufacturer
Draeger Medical, Inc.
1 Event
Recall of Device Recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
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Manufacturer
Draeger Medical, Inc.
Manufacturer Address
Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
Manufacturer Parent Company (2017)
Stefan Dräger GmbH
Source
USFDA
Language
English
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