FDAClass IIOctober 27, 2021

Canon Pet-ct Scanner recall: Software Issue

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

Why was Canon Pet-ct Scanner recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Affected serial numbers: 3DA1982001, 3DA2072002, 3DA2072003

Product
Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
Recalling firm
Canon Medical System, USA, INC.
Quantity
3 units
Distribution
US Nationwide distribution in the states of NV, AR MN.
Recall date
October 27, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls