Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1585-2015 · Posted 2015-05-06

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2015-02-03
Date Terminated2015-05-20
Product Quantity1 unit

Reason for Recall

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

Firm Action

Fuji Film on 2/3/15, issued a User Notification letter and the recovery procedure were hand carried to the user. A copy of Notification Letter is user's acknowledgement of receipt of the manual .

Root Cause

Labeling Change Control

Distribution Pattern

Distributed in HI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110729ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEMFujifilm Medical Systems U.S.A, Inc. · 2011-09-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑