Z-0386-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- July 14, 2017
- Termination Date
- July 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 US 1 OUS
Product 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 for Recall
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Distribution Pattern
US Distribution and Internationally to Mexico.
Code Information
FDR MS-3500 : S/N- 76221095 or earlier