Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2018 - (Recall #: Z-0385-2018)

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 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.

Product Classification:

Class II

Date Initiated: July 14, 2017

Date Posted: January 24, 2018

Recall Number: Z-0385-2018

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: 20 US

Code Information:

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

Distribution Pattern:

US Distribution and Internationally to Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated