Merge RadSuite software. The firm name on the label is recall
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Why was Merge RadSuite software. The firm name on the label is recalled?
The values provided from the Pixel Value tool do not appear to be correct, 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?
Version V8.30.7.8
- Product
- Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 8 sites have the potentially affected version
- Distribution
- US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
- Recall date
- February 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)