Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2018 - (Recall #: Z-0386-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 14, 2017

Date Posted: January 24, 2018

Recall Number: Z-0386-2018

Event ID: 78891

Reason for Recall:

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

Status: Terminated

Product Quantity: 15 US 1 OUS

Code Information:

FDR MS-3500 : S/N- 76221095 or earlier

Distribution Pattern:

US Distribution and Internationally to Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated