Recall Monitor
Health Products

ASPIRE Cristalle Mammography System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: ASPIRE Cristalle Mammography System
Issue: Medical devices - Unauthorised device
What to do: The importer Christie Innomed by e-mail at: qualite.quality@christieinnomed.com
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
ASPIRE Cristalle Mammography SystemCLLE-0229FDR-3000AWS

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

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