FDA Device recall Z-1272-2024
Synapse PACS - Version 7.2.200
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of Synapse PACS - Version 7.2.200 by Fujifilm Healthcare Americas, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1272-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-10 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fujifilm Healthcare Americas |
| Distribution | US |
Product
Synapse PACS - Version 7.2.200
Reason
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.
Identifiers
| code_info | Software Version: 7.2.200, UDI: (01)854904006008(10)0702200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1272-2024%22
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