FDANovember 9, 2020device
Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.
What to do
FDA enforcement status: Terminated
Brands named
canon medical systemcanoncanon medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDANicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.2026-05-14
- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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