FDAHealthJune 19, 2025
DIGIMED CO., LTD — Portable X-ray system
⚠️ Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- June 19, 2025
US
What's affected?
- Product
- Portable X-ray system
- Brand
- DIGIMED CO., LTD
- Lot code
- UDI-DI/Model Name: 08800021800014/DIOX-602
Additional details
UDI-DI/Model Name: 08800021800014/DIOX-602
What should I do?
Recommended action
Class II recall. FDA Mandated Quantity affected: 530.
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