Devices

Device Recall iConnect Access

Model / Serial
iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Product Description
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Manufacturer
Merge Healthcare, Inc.
1 Event
- Recall of Device Recall iConnect Access

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

2 devices with a similar name

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Device Recall iConnect Access used with Ortho PACS software

Model / Serial
iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand. There was no military or government distribution.
Product Description
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
Manufacturer
Merge Healthcare, Inc.

Device Recall iConnect Access

Model / Serial
Versions 3.0.1, 3.1, and 3.2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Distribution was made to medical facilities nationwide. Foreign distribution was also made.
Product Description
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Manufacturer
Merge Healthcare, Inc.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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