FDAClass IIMay 13, 2015

Aspire HD recall

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

Why was Aspire HD recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number: 26320119

Product
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast…
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
1 unit
Distribution
Distributed in HI.
Recall date
May 13, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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