Recall Z-0549-2021— Canon Medical System, USA, INC.

Name: FDA recall Z-0549-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-09

Class II · Terminated

Class II FDA medical device recall by Canon Medical System, USA, INC., initiated 2020-11-09, terminated 2022-12-16. It names one FDA 510(k) clearance: K192832. 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: 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..

Recalling firm: Canon Medical System, USA, INC.
Classification: Class II
Status: Terminated
Initiated: 2020-11-09
Terminated: 2022-12-16
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K192832 — Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation·cleared 2020-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.