Official recall notice

FDA DeviceClass IINotable

FDA Recall: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

Recall date
2026-09-02
FDA class
Class II

Why it was recalled

Hazard

Software issue may cause the ruler measurement to be inaccurate.

Product description

Software issue may cause the ruler measurement to be inaccurate.

Affected products

UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38

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