Device product
ASPIRE Cristalle (FDR MS-3500) 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.
Z-0386-2018
Product summary
- Event
- Event 78891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 US 1 OUS
- Official record key
device-enforcement:Z-0386-2018
Official wording
Reason: There was a case that the swivel arm went down unintentionally when it was moved up/down.
Code information: FDR MS-3500 : S/N- 76221095 or earlier
Distribution pattern: US Distribution and Internationally to Mexico.
Derived failure modes
-
Unknown
There was a case that the swivel arm went down unintentionally when it was moved up/down.