Data Foundry

Medical device recalls 2020

Canon Aquilion Prime SP — Class II medical device recall Z-0549-2021

Terminated recall by Canon Medical System, USA, INC., reported 2020-12-16, distributed nationwide. A software problem has been identified which could result in the CT Scanner not proceeding to the next actual

Recall numberZ-0549-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCanon Medical System, USA, INC., Tustin, CA, United States
Recall initiated2020-11-09
Classified2020-12-09
Reported by FDA2020-12-16
Terminated2022-12-16
DistributedNationwide (US)
Quantity60 units
Reason classessoftware
Serial numbers1LB1922175, 8LA19X2002, 8LA19X2003, 8LA19X2004, 8LA19X2005, 8LA19X2006, 8LA19X2007, 8LA19X2008, 8LA19X2009, 8LA19X2010, 8LA19Y2011, 8LA19Y2012, 8LA19Y2014, 8LA19Y2015, 8LA19Y2016, 8LA19Y2017, 8LA19Y2018, 8LA19Y2019, 8LA19Y2020, 8LA19Y2021, 8LA19Y2022, 8LA19Z2023, 8LA19Z2024, 8LA19Z2025, 8LA19Z2026 and 44 more

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0549-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.