FDA recall Z-2471-2020

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

Product

Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)

Reason for recall

Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2020-05-22
Report date: 2020-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2471-2020