Class 2 Device Recall DIOX602, Portable Xray system

• Date Initiated by Firm: June 19, 2025
• Date Posted: July 18, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2117-2025
• Recall Event ID: 97270
• 510(K)Number: K082167
• Product Classification: Unit, x-ray, extraoral with timer - Product Code EHD
• Product: Portable X-ray system
• Code Information: UDI-DI/Model Name: 08800021800014/DIOX-602
• Recalling Firm/ Manufacturer: DIGIMED CO., LTD; 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu; Seoul Korea (the Republic of)
• Manufacturer Reason for Recall: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: DIGIMED Co., Ltd. sends Field Safety Notice / Urgent Device Correction, notifying customers of the Issue, Potential Risk, Required Customer Actions with Customer Acknowledgment Form with Return Instructions.
• Quantity in Commerce: 530
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = EHD