Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86864

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 09, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Canon Medical System, USA, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0549-2021
Recall number
Z-0549-2021
Initiated
November 09, 2020
Classification
Class II
Status
Terminated
Quantity
60 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software problem

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers: 8LA2052063, 8LA19Z2034 , 8LA19X2004, 8LA19Z2027, 8LA19Z2029, 8LA2052062, 8LA2042055, 8LA19Z2032, 8OA2052059, 8LA2042051, 8LA2032044, 8LA19X2002, 1LB1922175, 8LA2042050, 8LA19X2007, 8LA2012037, 8LA19Y2021, 8LA19Y2014, 8LA2042056, 8LA19Z2023, 8LA2052067, 8LA19Z2031, 8LA19Y2019, 8LA19Z2030, 8OA19Y2013, 8LA19Z2028, 8LA19Y2012, 8LA19Y2020, 8LA2032042, 8LA2052066, 8LA19X2003, 8LA19Y2022, 8LA19X2008, 8LA2042047, 8LA19Z2024, 8LA2032046, 8LA19Z2033, 8OA2042053, 8LA2012036, 8LA2042054, 8LA19Z2025, 8LA19Z2026, 8LA2022041, 8LA19X2010, 8LA2032043, 8OA19X2001, 8OA2052061, 8OA2042049, 8LA19Y2016, 8LA2022039, 8LA19Y2015, 8LA2012035, 8LA2032045, 8LA19Y2018, 8LA19X2005, 8LA19X2006, 8LA19X2009, 8LA19Y2011, 8LA19Y2017, 8LA2012038, 8LA2052060, 8LA2052058 , 8LA2052064, 8LA2052065, 8LA2052068, 8LA2022040, 8OA2042052, 8LA2042048, 8LA2052057

Distribution pattern

US Nationwide distribution. OUS: Unknown