FDA Enforcement
Class II
Terminated
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.
Recall: Z-0386-2018
·
Reported January 24, 2018
Enforcement
- Recall Number
- Z-0386-2018
- 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 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.
Reason
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Code Info
FDR MS-3500 : S/N- 76221095 or earlier
Distribution
US Distribution and Internationally to Mexico.
Quantity
15 US 1 OUS