FDASeptember 6, 2024device
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
What to do
FDA enforcement status: Ongoing
Brands named
shimadzu corporation medical systems divisionshimadzushimadzu corporation
UPCs
0454021706480904540217064816
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
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- FDAOctopus Evolution AS Tissue Stabilizer, Model TS25002026-05-12
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- FDAMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software2026-05-12
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