Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 17, 2016
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merge Healthcare, Inc. recalled Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but l… - a moderate-severity action.
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but l… was recalled by Merge Healthcare, Inc. in August 17, 2016. Reason: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.. Check the official notice for the remedy. Verify recall #Z-2379-2016 with the FDA Devices before acting.
The recall
Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-The patient name in the Halo title bar and the thumbnails do not match the name on displayed images..
- Moderate
- severity level
- Class II
- classification
- August 17, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2379-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2379-2016) was formally reported on August 17, 2016, with the manufacturer initiating the action on January 30, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Merge Healthcare, Inc. is listed as the recalling firm, operating out of Hartland, WI. Federal records list the affected scope as 93 sites have the affected version.
The documented reason for this recall is: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
93 sites have the affected version
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2379-2016 |
| Date reported | August 17, 2016 |
| Date initiated | January 30, 2016 |
| Recalling firm | Merge Healthcare, Inc. |
| Firm location | Hartland, WI |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2379-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2379-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 17, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.