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Device Recall Merge OrthoPACS
Model / Serial
Versions 6.6, 6.6.1, and 6.6.2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.
Product Description
Merge OrthoPACS software.
Manufacturer
Merge Healthcare, Inc.
1 Event
Recall of Device Recall Merge OrthoPACS
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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
One device with a similar name
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Device Recall Merge OrthoPACS
Model / Serial
Versions 6.6, 6.6.1, 6.6.2, 6.6.2.1, and 6.6.2.2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
USA (nationwide) Distribution was made to medical facilities. There was no foreign/government/military distribution.
Product Description
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Manufacturer
Merge Healthcare, Inc.
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