Aspire Cristalle Mammography System

Recall Summary The ASPIRE Cristalle Mammography System is being recalled in Canada because it is an unauthorised device that has not been approved for sale in Canada. This recall affects all units of this mammography system that were distributed across Canada.

Product
ASPIRE Cristalle Mammography System
Reason
Unauthorised device
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2025-07-03
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fd5f4720-6510-4d56-a813-ce387ff91c38