Recall Z-0939-2019— Merge Healthcare, Inc.

Name: FDA recall Z-0939-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2018-12-20, terminated 2023-02-28. It names one FDA 510(k) clearance: K982689. 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 retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.. Reason: 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)..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-20
Terminated: 2023-02-28
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K982689 — WINSTATION RETINAL IMAGEROphthalmic Imaging Systems·cleared 1998-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.