Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2016 - (Recall #: Z-2690-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 9, 2016

Date Posted: September 7, 2016

Recall Number: Z-2690-2016

Event ID: 74525

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 Units

Code Information:

26330437 and 17230408

Distribution Pattern:

US Distribution to: NC and HI.

Voluntary or Mandated:

Voluntary: Firm initiated