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Devices
Infant Warmer System (IWS)
Model / Serial
Medical device listing number: D103053, D103054, D103056, D103057, D183529
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
This product has been distributed domestically and internationally .
Product Description
Infant Warmer System (IWS)
Manufacturer
GE Healthcare, LLC
1 Event
Recall of Infant Warmer System (IWS)
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Manufacturer
GE Healthcare, LLC
Manufacturer Address
GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Manufacturer Parent Company (2017)
General Electric Company
Source
USFDA
5 devices with a similar name
Learn more about the data
here
Ohio Infant Warmer System (IWS)
Model / Serial
Manufacturer
Ohmeda Medical (Datex-Ohmeda)
Infant Warmer System (IWS) Hot “Heater Head”
Model / Serial
Affected model numbers: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300 IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS. .................................................. NCMDR update codes : Two additional model numbers to the Affected Product Details section; 3051 IWS and 3400 IWS
Product Description
Heating unit
Manufacturer
GE Healthcare
Infant Warmer System (IWS)
Model / Serial
Product Description
Surgical equipment/ Anaesthesia - surgical equipment
Manufacturer
GE Healthcare
Infant Warmer System (IWS)
Model / Serial
Infant Warmer System (IWS)Model Numbers: 3000 IWS, 3300 IWS, 3400 IWS and 4400 IWSARTG Number: 139290
Manufacturer
GE Healthcare Australia Pty Ltd
Infant Warmer System (IWS) Hot “Heater Head” Screw
Model / Serial
Manufacturer
GE Healthcare
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