FDANovember 11, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

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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Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A — Recall Details · AllClear