Portable X-ray system
FDA Recall Z-2117-2025 · Posted 2025-07-18
Recalling FirmDIGIMED CO., LTD
Recall StatusOpen, Classified
Product CodeEHD
Date Initiated2025-06-19
Product Quantity530
Reason for Recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.