Reported Jan 18, 2017 · Terminated
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager…
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?
- Merge Eye Station f/k/aDFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS)
- Versions11.6.0 and prior
- Lot codes and dates
- Merge Eye Station software versions11.6.0 and prior
- Amount recalled
- 1597 (1451 US; 146 OUS)
Where it was sold
Why it was recalled
This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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