FDA recall Z-0386-2018

Fujifilm Medical Systems U.S.A., Inc. · Class II · 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.

Reason for recall

There was a case that the swivel arm went down unintentionally when it was moved up/down.

Distribution

US Distribution and Internationally to Mexico.

Key facts

Status
Terminated
Initiation date
2017-07-14
Report date
2018-01-24
Termination date
2018-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stamford, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0386-2018