Recall Z-2117-2025 ยท EHD Unit, X-Ray, Extraoral With Timer
DIGIMED CO., LTD
Portable X-ray system
| Date | Jul 18, 2025 (initiated Jun 19, 2025) |
| Status | Open, Classified |
| Reason | Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. |
| Root 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 | 530 |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX Digimed Corporation, Sep 26, 2008 |