Merge Healthcare Recalls Eye Station Imaging Devices Due to Capture Failures
Merge Healthcare is recalling 182 Eye Station capture stations because they may fail to capture eye images as intended, posing a risk to patient health.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk to patient health due to device malfunction, but the source text does not report any specific injuries, hospitalizations, or fatalities, fitting the criteria for a High severity score.
Plain-English summary
Merge Healthcare, Inc. is recalling 182 Merge Eye Station capture stations, including 136 T1700 and 46 T5810 models. These devices, formerly known as DFC-1024 & DFC-512 Digital Imaging Systems, WinStation, and WinStation Retinal Imager, were distributed by Ophthalmic Imaging Systems (OIS).
The recall was initiated after the company received reports that the devices were unable to capture images of the eye as expected per their intended use. Merge is removing the product from the field to reduce the risk to patient health.
The affected units were distributed worldwide, including nationwide in the United States and in Canada and the United Kingdom. Healthcare facilities and consumers with these specific models should contact Merge Healthcare for instructions on how to proceed.
The recalled product
- Product
- Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 182
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 136 T1700 Capture Stations 46 T5810 Capture Stations
Distribution
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