FUJIFILM Healthcare Americas Corporation: Device Recall

Recall Details

Recall Number

Z-2219-2025

Classification

Class II

Product Type

Device

Recalling Firm

FUJIFILM Healthcare Americas Corporation

Status

Ongoing

Date Initiated

06/11/2025

Location

Lexington, MA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

293 units

Reason for Recall

Devices had an unapproved slabbing software function enabled for use.

Product Description

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

Distribution Pattern

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

Other Recalls by FUJIFILM Healthcare Americas Corporation

• Class II: Risk 01/09/2026
  It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
• Class II: Risk 09/15/2025
  It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
• Class II: Risk 02/11/2025
  The incorrect computed patient age is showing in VX for patients less than 3 months old.

View all recalls by FUJIFILM Healthcare Americas Corporation →