Portable X-ray system
FDA device recall Z-2117-2025 · posted 2025-07-18 · Open, Classified
Recall details
- Recalling firm
- DIGIMED CO., LTD
- Reason for recall
- Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- EHD
- Quantity affected
- 530
- Distribution
- US
- Date initiated
- 2025-06-19
- Date posted
- 2025-07-18
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX (K082167) | Digimed Corporation | 2008-09-26 |