Merge OrthoCase software. The firm name on the label is recall: Software Issue
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Why was Merge OrthoCase software. The firm name on the label is recalled?
Measurements in the software are changing after saving a plan with a measurement result, 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: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3
- Product
- Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 30 sites potentially have the effected versions
- Distribution
- Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)