Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recalls in 2016

According to to data from the FDA, there were 9 medical device recalls made by Fujifilm Medical Systems U.S.A., Inc. in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

• Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
• Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
• Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage
• Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
• Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
• Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
• Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
• Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
• FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.