FDA Recall
Open, Classified
Portable X-ray system
Recall: Z-2117-2025
·
Initiated June 19, 2025
Recall
- Recall Number
- Z-2117-2025
- Event Number
- 97270
- Firm
- DIGIMED CO., LTD 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu Seoul Korea (the Republic of)
- FEI Number
- 3007933232
- Product Code
- EHD
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- June 19, 2025
- Posted
- July 18, 2025
Description
Portable X-ray system
Reason
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
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.
Distribution
US
Quantity
530