ASPIRE Cristalle Mammography System
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| ASPIRE Cristalle Mammography System | CLLE-0229 | FDR-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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Fujifilm Corporation
26-30 Nishiazabu, Minato-Ku, Tokyo-To, Japan, 106-8620
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77666
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