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.
Enforcement
- Recall Number
- Z-0385-2018
- Event ID
- 78891
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2018
- Initiation Date
- July 14, 2017
- Classification Date
- January 18, 2018
- Termination Date
- July 20, 2018
- Address
- 419 West Ave, N/A, Stamford, CT, 06902-6343, United States
Description
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.
There was a case that the swivel arm went down unintentionally when it was moved up/down.
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
US Distribution and Internationally to Mexico.
20 US