Reported Mar 6, 2019 · Terminated
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
- The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512
- Digital Imaging System Product UsageThe 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
- Lot codes and dates
- UDI00842000100140
- Serial Numbers
1,247 of 1,247 codes
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
- Amount recalled
- 1,252 Units
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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