Public recall detail

ASPIRE Cristalle Mammography System

2025-07-03

medium
Recall Safety notice
Quick summary

Quick summary: ASPIRE Cristalle Mammography System. Date: 2025-07-03.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: ASPIRE Cristalle Mammography System. Date: 2025-07-03.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandFujifilm Corporation
ProductASPIRE Cristalle Mammography System
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-77666

Affected products

ProductASPIRE Cristalle Mammography System
LotCLLE-0229
ModelFDR-3000AWS
Serial numberCLLE-0229
DescriptionASPIRE Cristalle Mammography System

Issue

FujiFilm became aware of an issue with the "maximum intensity projection ("MIP") service configuration setting, which setting may have been changed during installation from its default "no" setting to a "yes" setting. If this setting is in the "yes" position, it enables the slabbing function. This function is not approved for use in Canada. Recall start date: June 20, 2025

What you should do

  • The importer Christie Innomed by e-mail at: qualite.quality@christieinnomed.com
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesFujifilm Corporation 26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77666
Background{}
CompaniesFujifilm Corporation 26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
AudiencesHealthcare
Source updated2025-07-03

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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