Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recalls in 2021

According to to data from the FDA, there were 6 medical device recalls made by Fujifilm Medical Systems U.S.A., Inc. in 2021. See the details of the recalls below.

You can see similar recalls for other firms.

• Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
• Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
• FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - 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.
• Synapse PACS Software Versions 5.1 and higher
• Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
• ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit