DIGIMED CO., LTD: Device Recall
Recall #Z-2117-2025 · 06/19/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2117-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DIGIMED CO., LTD
- Status
- Ongoing
- Date Initiated
- 06/19/2025
- Location
- Seoul, N/A, Korea (the Republic of)
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 530
Reason for Recall
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Product Description
Portable X-ray system
Distribution Pattern
US
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.