ASPIRE Cristalle Mammography System recall in Canada: Unauthorized device
In plain language
This recall involves the ASPIRE Cristalle Mammography System sold in Canada. It's being recalled because a specific function, the "slabbing function," is not approved for use in Canada. Healthcare professionals should contact the importer for instructions.
What to do
- Stop using the unauthorized "slabbing function" on the ASPIRE Cristalle Mammography System.
- Contact the importer, Christie Innomed, by email at qualite.quality@christieinnomed.com.
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Affected products
ASPIRE Cristalle Mammography System
Model: FDR-3000AWS
Lot: CLLE-0229
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: CLLE-0229
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: FDR-3000AWS
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves the ASPIRE Cristalle Mammography System sold in Canada. It's being recalled because a specific function, the "slabbing function," is not approved for use in Canada. Healthcare professionals should contact the importer for instructions.
What should consumers do?
Stop using the unauthorized "slabbing function" on the ASPIRE Cristalle Mammography System. Contact the importer, Christie Innomed, by email at qualite.quality@christieinnomed.com.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on July 3, 2025.
Is the Fujifilm Corporation brand affected by this recall?
Yes, Fujifilm Corporation products are affected by this recall. This recall involves the ASPIRE Cristalle Mammography System sold in Canada. It's being recalled because a specific function, the "slabbing function," is not approved for use in Canada. Healthcare professionals should contact the importer for instructions.