Recall Z-1585-2015— Fujifilm Medical Systems U.S.A., Inc.

Name: FDA recall Z-1585-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-03

Class II · Terminated

Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2015-02-03, terminated 2015-05-20. It names one FDA 510(k) clearance: K110729. Product: Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.. Reason: User Manual lacks a description for handling some errors even though the system can be recovered from such errors.

Recalling firm: Fujifilm Medical Systems U.S.A., Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-03
Terminated: 2015-05-20
Firm location: Stamford, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K110729 — ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEMFujifilm Medical Systems U.S.A, Inc.·cleared 2011-09-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.