Recall Z-2043-2016— Fujifilm Medical Systems U.S.A., Inc.
Class II · Terminated
Class II FDA medical device recall by Fujifilm Medical Systems U.S.A., Inc., initiated 2016-05-10, terminated 2019-02-20. It names one FDA 510(k) clearance: K112439. Product: 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.. Reason: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead.
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-10
- Terminated
- 2019-02-20
- Firm location
- Stamford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Data sourced from openFDA. This site is unofficial and independent of the FDA.