FDAFDA · Food and drugs·Recall number Z-1498-2017
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Published March 29, 2017 · Recall initiated: April 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Merge Healthcare, Inc.
- Distributor
- Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
- Lot
- Versions 1.1.2 and 1.1.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.