Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-1585-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.

Product Classification:

Class II

Date Initiated: February 3, 2015

Date Posted: May 13, 2015

Recall Number: Z-1585-2015

Event ID: 70854

Reason for Recall:

User Manual lacks a description for handling some errors even though the system can be recovered from such errors

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial Number: 26320119

Distribution Pattern:

Distributed in HI.

Voluntary or Mandated:

Voluntary: Firm initiated