Canon Medical System, USA, INC.: Medical Device Recall in 2021 - (Recall #: Z-0142-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 11, 2020

Date Posted: October 27, 2021

Recall Number: Z-0142-2022

Event ID: 88691

Reason for Recall:

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the states of NV, AR MN.

Voluntary or Mandated:

Voluntary: Firm initiated