Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2020 - (Recall #: Z-0282-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

Product Classification:

Class II

Date Initiated: September 11, 2020

Date Posted: October 28, 2020

Recall Number: Z-0282-2021

Event ID: 86494

Reason for Recall:

FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

Status: Terminated

Product Quantity: 1

Code Information:

Synapse Software Version 5.6.1

Distribution Pattern:

US Nationwide distribution including in the state of Minnesota.

Voluntary or Mandated:

Voluntary: Firm initiated