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Canon Medical System, USA, INC. recalls Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cro
Recalled December 16, 2020 · FDA recall Z-0549-2021 · Canon Medical System, USA
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. · FDA Class II
Units
60 units
Sold at
US Nationwide distribution. OUS: Unknown
Description
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.
Product
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.
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →