Recall record at a glance
| Official record | Z-2062-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Merge Healthcare, Inc. |
| Report date | Jul 31, 2019 |
| Recall initiation date | Jul 11, 2019 |
| Quantity | 179 devices |
| Location | Hartland, WI, United States |
Official product description
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Why the product was recalled
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Distribution information
Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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