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Portable X-ray system

FDA Recall #Z-2117-2025 — Class II — June 19, 2025

Recall #Z-2117-2025 Date: June 19, 2025 Classification: Class II Status: Ongoing

Product Description

Portable X-ray system

Reason for Recall

Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

Recalling Firm

DIGIMED CO., LTD — Seoul, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

530

Distribution

US

Code Information

UDI-DI/Model Name: 08800021800014/DIOX-602

Status

Ongoing

Voluntary / Mandated

FDA Mandated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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