medical Class II Updated 2021-10-27

Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A

Recalled Product

Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003
View official government recall

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