Home / Recalls / DIGIMED CO., LTD / Z-2117-2025

Z-2117-2025 Class II Ongoing

Recalled by DIGIMED CO., LTD — Seoul, N/A

Recall Details

Product Type
Devices
Report Date
July 30, 2025
Initiation Date
June 19, 2025
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
530

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.

Distribution Pattern

US

Code Information

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