Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Reported: August 17, 2016 Initiated: January 30, 2016 #Z-2379-2016
Product Description
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Reason for Recall
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 93 sites have the affected version
- Distribution
- The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.. Recalled by Merge Healthcare, Inc.. Units affected: 93 sites have the affected version.
Why was this product recalled? ▼
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2379-2016.
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