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Devices
RadSuite iConnect
Model / Serial
iConnect Enterprise Archive versions 5.30.0 thru 9.4.3 and V11.0.
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
Product Description
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
Manufacturer
Merge Healthcare, Inc.
1 Event
Recall of RadSuite iConnect
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Manufacturer
Merge Healthcare, Inc.
Manufacturer Address
Merge Healthcare, Inc., 900 Walnut Ridge Dr, Hartland WI 53029-8347
Manufacturer Parent Company (2017)
International Business Machines Corp.
Source
USFDA
Language
English
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