FDAOctober 8, 2015device
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Terminated
Brands named
merge healthcaremerge
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAGE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.2026-03-24
- FDAGE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.2026-03-24
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