CADstream software. The firm name on the label is Merge recall: Software Issue
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Why was CADstream software. The firm name on the label is Merge recalled?
The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.
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 prior to 5.2.9
- Product
- CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 844 sites potentially have the affected versions
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution. Foreign/military/government distribution was also made.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)