FDA recall Z-0282-2021

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

Product

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.

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.

Distribution

US Nationwide distribution including in the state of Minnesota.

Key facts

Status: Terminated
Initiation date: 2020-09-11
Report date: 2020-10-28
Termination date: 2021-11-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0282-2021