The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage:

FDA device recall Z-0939-2019 · posted 2019-02-25 · Terminated

Recall details

Recalling firm

Merge Healthcare, Inc.

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).

Action taken

On about 12/20/2018 Merge Healthcare notified customers via "Urgent Field Safety Notice." The notice informed customers that certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. A 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). Instructions included to immediately cease use of all Eye Station hardware and that a Merge Healthcare representative will contact each customer to schedule a correction once the modification is available. Questions regarding the recall notification can be directed to customer support at Eyecaresupport@us.ibm.com or 877-741-5369.

Root cause

Device Design

Status

Terminated

Product code

HKI

Quantity affected

1,252 Units

Distribution

Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Loui

Date initiated

2018-12-20

Date posted

2019-02-25

Date terminated

2023-02-28

Location

Hartland, WI

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