FDA recall Z-0878-2021

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

Product

Synapse PACS Software Versions 5.1 and higher

Reason for recall

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

Distribution

Software was distributed to medical facilities nationwide throughout the U.S.

Key facts

Status: Ongoing
Initiation date: 2020-09-11
Report date: 2021-01-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lexington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2021