FDA Device recall Z-3030-2026
FUJIFILM Synapse PACS software v7.4.310
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of FUJIFILM Synapse PACS software v7.4.310 by Fujifilm Healthcare Americas, citing software issue may cause the ruler measurement to be inaccurate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3030-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-22 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fujifilm Healthcare Americas |
| Distribution | US |
Product
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Reason
Software issue may cause the ruler measurement to be inaccurate.
Identifiers
| code_info | UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3030-2026%22
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