Fujifilm Medical Systems U.S.A., Inc. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. Matched by name to FUJIY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a managementClass IIApr 30, 2021Software versions 6.0.4 to 6.2.1 using Advanced Reporting -p	Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal pat	Class IIDevices	Apr 30, 2021
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on anClass IIMar 2, 2021The wrong patient information may be displayed in the viewer	The wrong patient information may be displayed in the viewer or PowerJacket.	Class IIDevices	Mar 2, 2021
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kitClass IIFeb 18, 2021Potentially defective Chip Cassette units, when used for DCP	Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3%	Class IIDevices	Feb 18, 2021