Fujifilm Medical Systems U.S.A., Inc.
Lexington, MA
This page shows every FDA and USDA recall linked to Fujifilm Medical Systems U.S.A., Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
10
Total Recalls
2019
First Recall
2021
Most Recent
Synapse Cardiovascular (Synapse CV).
Software Versions: 6.0 to 6.2.1
The Synapse Cardiovascular image is a...
Apr 30, 2021
· Device
Terminated
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based applicat...
Mar 2, 2021
· Device
Open, Classified
TASWako Chip Cassette is part of the Wako TASWako i30 kit
Feb 18, 2021
· Device
Terminated
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for th...
Dec 22, 2020
· Device
Terminated
FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based app...
Dec 11, 2020
· Device
Terminated
Synapse PACS Software Versions 5.1 and higher
Sep 11, 2020
· Device
Open, Classified
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the...
Sep 11, 2020
· Device
Terminated
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS So...
May 22, 2020
· Device
Open, Classified
Fujifilm FDR Go Plus mobile X-ray system
Jul 19, 2019
· Device
Terminated
Fujifilm FDR Go PLUS, Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film,...
Jan 15, 2019
· Device
Terminated