Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reported: August 17, 2016 Initiated: February 5, 2016 #Z-2363-2016
Product Description
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Reason for Recall
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Details
- Recalling Firm
- Merge Healthcare, Inc.
- Units Affected
- 49 sites potentially have the affected versions
- Distribution
- Worldwide Distribution -- USA and Australia.
- Location
- Hartland, WI
Frequently Asked Questions
What product was recalled? ▼
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.. Recalled by Merge Healthcare, Inc.. Units affected: 49 sites potentially have the affected versions.
Why was this product recalled? ▼
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2363-2016.
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