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Devices
Device Recall Evita XL Continuous Ventilator
Model / Serial
Catalog number 8414900. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part number 8306611 replaced between January 2005 and May 2008. The serial number for the affected CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
Product Description
Evita XL Critical Care Ventilator. Continuous (Respirator)
Manufacturer
Draeger Medical, Inc.
1 Event
Recall of Device Recall Evita XL Continuous Ventilator
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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
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