Merge Eye Station Import Utility recall
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Why was Merge Eye Station Import Utility recalled?
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Versions 1.1.2 and 1.1.3
- Product
- Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 78 sites potentially have the affected accessory
- Distribution
- Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)