Fusion Workstation recall
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Why was Fusion Workstation recalled?
After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.
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 V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.
- Product
- Fusion Workstation.; Indicated for the transmission and review of radiological images.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 13 sites potentially hae the affected version
- Distribution
- Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.
- Recall date
- October 26, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)