Device 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.
Z-1585-2015
Product summary
- Event
- Event 70854
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1585-2015
Official wording
Reason: User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Code information: Serial Number: 26320119
Distribution pattern: Distributed in HI.
Derived failure modes
-
Unknown
User Manual lacks a description for handling some errors even though the system can be recovered from such errors