Z-3030-2026Class II

FUJIFILM Healthcare Americas Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-09-02

Distribution

Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.

Firm state

Product quantity

6 units

Initiated by

Voluntary: Firm initiated

Reason for recall

Software issue may cause the ruler measurement to be inaccurate.

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →