FDAJanuary 30, 2016device
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Patient information in the header is only found on the first page of the report and not on the subsequent pages.
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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