Portable X-ray system

Recall: Z-2117-2025 · Reported July 30, 2025

Enforcement

Recall Number: Z-2117-2025
Event ID: 97270
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: DIGIMED CO., LTD
Voluntary / Mandated: FDA Mandated
Initial Notification: N/A
Report Date: July 30, 2025
Initiation Date: June 19, 2025
Classification Date: July 18, 2025
Address: 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu, N/A, Seoul, N/A, N/A, Korea (the Republic of)

Reason

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

Code Info

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

Distribution

Quantity

530