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Devices
Merge PACS software. The firm name on the label is Merge Healthcare.
Model / Serial
Versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, and 7.0.1
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide ) Distribution was made to medical facilities. Internationally to Canada. There was no government or military distribution.
Product Description
Merge PACS software. The firm name on the label is Merge Healthcare.
Manufacturer
Merge Healthcare, Inc.
1 Event
Recall of Merge PACS software. The firm name on the label is Merge Healthcare.
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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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