Recall Z-2043-2016 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
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 o
| Date | May 10, 2016 |
| Status | Terminated |
| Reason | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead |
| Root cause | Software design |
| Action | The firm, FujiFilm, sent an "MEDICAL DEVICE CORRECTION" letter dated May 10, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken.The customers were instructed to: Extend the Ad hoc deletion retention period or discontinue use of Ad Hoc Deletion, and complete and submit the attached Customer Response Form to Fujifilm via fax to (203)-251-7863. Affected systems will be corrected via on-site visits by FMSU Customer Service Engineers upgrading to Version 4.4.100. Questions or concerns, contact the FUJI FILM Customer Support Center at 1- 888 |
| Quantity | 27 units |
| Distribution | US Distribution to states of: CA, FL, KS, NE, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112439 | SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 Fujifilm Medical System U.S.A., Inc., Oct 17, 2011 |