| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01329-1 |
| Product Name/Description |
Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system)
ARTG Number: 203605 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified with the image processing software module when two or more patient FCR images (Fuji Computed Radiology images stored in a proprietry format) from Synapse PACS are sent simultaneously to another manufacturer's PACS . When FCR images (comprised of pixel data and the DICOM header) are sent via CMOVE or forwarded by EBF (Event Based Forwarding) on multiple associations simultaneously, in rare situations, one or more of the following issues can happen: a) Patient A’s pixel data is changed to patient B’s pixel data and forwarded to the destination. b) The output image is corrupted and may appear as random noise. c) DicomServer crashes. If issue a) or b) happens, only the image in the destination archive is affected. Images in the Source Synapse System are not affected. The potential risk is that pixel data for a patient’s image may not be correct in the destination (non-Fujifilm) PACS. However, the radiology reports will be correct. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Fujifilm has applied a corrective software patch to affected PACS as a permanent fix.
This action has been closed-out on 20/11/2017. |
| Contact Information |
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