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Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Recalled October 27, 2021 · FDA recall Z-0142-2022 · Canon Medical System, USA
Hazard
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium. · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of NV, AR MN.
Description
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the diagnostic imaging system failing resulting in rescanning and reinjection of contrast medium.
Product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Manufacturer(s)
Canon Medical System, USA, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →