Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall Z-0385-2018 · Posted 2018-01-17
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Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeMUE
Date Initiated2017-07-14
Date Terminated2018-07-20
Product Quantity20 US
Reason for Recall
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Firm Action
FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers.
PLEASE READ AND FOLLOW THE INSTRUCTIONS
Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section.
We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue is very important to us.
If you have any questions about this matter, please contact your local FUJIFILM office. For further questions, please call (360) 356-6821.
Root Cause
Employee error
Distribution Pattern
US Distribution and Internationally to Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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