FDA-Device2017-03-29Class II
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Merge Healthcare, Inc.
Hazard
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Sold states
Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Affected count
78 sites potentially have the affected accessory
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1498-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief