FUJIFILM Healthcare Americas Corporation has recalled 293 units of the ASPIRE Cristalle Mammography System (cleared under K212873) that are equipped with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option. These devices were distributed with an unapproved "slabbing" software function enabled for use, which was not cleared for this specific equipment configuration. There have been no reports of incidents or injuries related to this issue, and the company has voluntarily initiated this action to correct the software configuration.
The use of unapproved imaging software functions in mammography systems could lead to errors in image processing or display, potentially affecting clinical diagnostic reviews. While no patient harm has been reported, the presence of uncleared software features on a medical imaging device poses a risk of diagnostic inconsistency.
System cleared under K212873; Digital Breast Tomosynthesis option approved under P160031.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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