Recall Z-0073-2017 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
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
| Date | Sep 15, 2016 |
| Status | Terminated |
| Reason | Image data for a patients image may not be correct |
| Root cause | Software design |
| Action | The firm, FMSU, sent a "Medical Device Correction" letter dated September 15, 2016 to its customers. The letter describes the product, problem and actions to be taken. The firm will install a patch that corrects the issue (Synapse IPSS v1.3.1.0 Patch).Customers with Version 4.0 may upgrade to version 4.4 (will not require the patch) or upgrade to 4.1, 4.2, or 4.3 and install the patch. FMSU will install the patch on the server remotely if your site uses Active Monitoring. Your notification that the patch was installed will be your service ticket. For sites not using Active Monitoring, FMSU wi |
| Quantity | 251 units |
| Distribution | US Nationwide Distribution. |
| 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 |