Merge Eye Station Retinal Imager Recalled for Electrical Safety Defects
Merge Healthcare is recalling 1,252 WinStation Retinal Imagers because certain configurations may produce electrical output exceeding allowable medical device limits.
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 involves a medical device with a risk of electrical shock (exceeding leakage current limits) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Merge Healthcare, Inc. is recalling 1,252 units of the WinStation Retinal Imager, also known as the Merge Eye Station (DCF-1024 & DCF-512 Digital Imaging System). The device is a medical imaging system used to produce color or black-and-white images of the retina and anterior segment, as well as fluorescein and ICG angiographic images, in a non-invasive manner.
The recall was initiated because certain configurations of the hardware may result in electrical output that exceeds allowable limits for medical devices. Specifically, 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).
The affected units were distributed nationwide to all 50 states and the District of Columbia, as well as internationally to Algeria, Austria, Belgium, Canada, the Czech Republic, Denmark, Germany, Israel, the Netherlands, Puerto Rico, and the United Kingdom. Healthcare facilities and consumers should stop using the affected devices and contact Merge Healthcare for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Merge Healthcare, Inc.
- Affected units
- 1,252
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 (20)
- UDI: 00842000100140. Serial Numbers: a0L3200000BVmMo
- a0L3200000DyTSA
- a0L3200000AiuLX
- a0L3200000BUou2
- a0L0e00000EPuiz
- a0L3200000BVZ7i
- a0L3200000Ajd0n
- a0L3200000C04Ol
- a0L3200000Aj6EX
- a0L32000009gkeu
- a0L3200000BUOXv
- a0L3200000Aj6TP
- a0L3200000BTnqr
- a0L3200000AjTBg
- a0L32000008q1mk
- a0L0e00000DzQ3a
- a0L3200000B2Csy
- a0L32000009hJZk
- a0L32000009n0mi
- a0L0e00000E0aFN
Distribution
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