FDA Device recall Z-1585-2015
Aspire HD, Full Field Digital, System, x-Ray, Mammographic
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of Aspire HD, Full Field Digital, System, x-Ray, Mammographic by Fujifilm Medical Systems U, citing user Manual lacks a description for handling some errors even though the system can be recovered from such errors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1585-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-03 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | HI |
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
Identifiers
| code_info | Serial Number: 26320119 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1585-2015%22
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