FDA recall Z-0549-2021

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

Product

Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head.

Reason for recall

A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the CT scan failing resulting in rescanning and reinjection of contrast medium.

Distribution

US Nationwide distribution. OUS: Unknown

Key facts

Status
Terminated
Initiation date
2020-11-09
Report date
2020-12-16
Termination date
2022-12-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0549-2021