FDA recall Z-0142-2022

Canon Medical System, USA, INC. · Class II · device

Product

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

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.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2020-11-11
Report date: 2021-10-27
Termination date: 2023-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0142-2022