Portable X-ray system
This recall is currently active, issued July 18, 2025. It was issued by Digimed Co., Ltd 401, 402, 406~411-Ho, A-Dong 101, Gasan Digital 2-Ro, Geumcheon-Gu Seoul Korea (The Republic Of).
- Recall Initiated
- June 19, 2025
- Posted
- July 18, 2025
- Recall Number
- Z-2117-2025
- Quantity
- 530
- Official Source
- View on FDA website ↗
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
US
Lot / Code Info
UDI-DI/Model Name: 08800021800014/DIOX-602
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.