FDA recall Z-2219-2025

Product

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

Reason for recall

Devices had an unapproved slabbing software function enabled for use.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.

Key facts

Status

Ongoing

Initiation date

2025-06-11

Report date

2025-08-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2025