Merge Healthcare recalls specific models of the Eye Station Retinal Imager (DCF-1024 & DCF-512) due to electrical output exceeding safety limits. This could cause electrical shock during use. Affected units have unique serial numbers listed in the recall notice.
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).
Merge Healthcare is recalling certain models of their Eye Station Retinal Imager (DCF-1024 & DCF-512) because electrical output may exceed safe limits. This could lead to electrical shock during use. The recall affects specific units with listed serial numbers.
The device's electrical output may exceed allowable limits for medical devices under certain conditions. This can result in electrical shock to users or patients, particularly if the device is not properly grounded.
Healthcare professionals who use the Eye Station Retinal Imager for retinal imaging are most at risk. Patients using the device could also be affected if the electrical hazard occurs during procedures.
Check the serial number on your device. Affected units have specific serial numbers listed in the recall notice. The device is used for retinal imaging and anterior segment imaging.
Look for the serial number on your Eye Station Retinal Imager. Affected units have specific serial numbers listed in the recall notice.
Reach out to Merge Healthcare directly for guidance on next steps if your device is affected.
Certain configurations of the Eye Station Retinal Imager may result in electrical output exceeding allowable limits for medical devices, which could cause electrical shock during use.
Check the serial number on your device. Affected units have specific serial numbers listed in the recall notice.
Contact Merge Healthcare directly for guidance on next steps if your device is affected.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0939-2019 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-0939-2019 from Merge Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
