Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to If an exposure is aborted during a stereo...

Date: June 9, 2016
Company: Fujifilm Medical Systems U.S.A., Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.

Affected Products

FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

Quantity: 2 Units

Why Was This Recalled?

If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly.

Where Was This Sold?

This product was distributed to 2 states: HI, NC

Affected (2 states)Not affected

About Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report