Merge Eye Station Import Utility recall
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare…
Why was Merge Eye Station Import Utility recalled?
Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)
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?
Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1
- Product
- Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare…
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 1,627 sites potentially have the affected versions
- Distribution
- Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)