Z-1585-2015 Class II Terminated
FDA device recall Z-1585-2015 was initiated by Fujifilm Medical Systems U.S.A., Inc. on Feb 3, 2015 and is designated Class II. Reason for recall: User Manual lacks a description for handling some errors even though the system can be recovered from such errors The recall status is terminated (terminated May 20, 2015). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- Feb 3, 2015
- Termination Date
- May 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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
Distribution Pattern
Distributed in HI.
Code Information
Serial Number: 26320119
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1585-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026