Device product
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). 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-0385-2018
Product summary
- Event
- Event 78891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 US
- Official record key
device-enforcement:Z-0385-2018
Official wording
Reason: There was a case that the swivel arm went down unintentionally when it was moved up/down.
Code information: FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 made in Japan : S/N- 16650001 or later FDR MS-2000 made in China : S/N- 26870001 or later
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.