Official recall record
Synapse Picture Archiving And Communications Systems (ref 75074)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-02-15
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues. Recall start date: January 30, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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