Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 6, 2019
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed all…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merge Healthcare, Inc. recalled The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digita… - a moderate-severity action.
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digita… was recalled by Merge Healthcare, Inc. in March 6, 2019. Reason: Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowab…. Check the official notice for the remedy. Verify recall #Z-0939-2019 with the FDA Devices before acting.
The recall
Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowab….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- March 6, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0939-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0939-2019) was formally reported on March 6, 2019, with the manufacturer initiating the action on December 20, 2018. 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 1,252 Units.
The documented reason for this recall is: Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, … Distribution data in the federal record shows the product reached: Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryl…. 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 - 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 - 40,422 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
1,252 Units
Related Recalls
6
0 from same agency
Product description
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
Reason for recall
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0939-2019 |
| Date reported | March 6, 2019 |
| Date initiated | December 20, 2018 |
| Recalling firm | Merge Healthcare, Inc. |
| Firm location | Hartland, WI |
| Affected scope | 1,252 Units |
| Distribution | Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts… |
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-0939-2019) 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? ▼
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.. Recalled by Merge Healthcare, Inc.. Units affected: 1,252 Units.
Why was this product recalled? ▼
Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2019. Severity: Moderate. Recall number: Z-0939-2019.
Where was the recalled product distributed? ▼
Distribution: Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West , Virginia, Wisconsin. International distribution to Algeria, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Israel, Netherlands, Puerto Rico, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0939-2019) 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 March 6, 2019. 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.