Device product
Portable X-ray system
Z-2117-2025
Product summary
- Firm
- DIGIMED CO., LTD
- Event
- Event 97270
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 530
- Official record key
device-enforcement:Z-2117-2025
Official wording
Reason: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Code information: UDI-DI/Model Name: 08800021800014/DIOX-602
Distribution pattern: US
Derived failure modes
-
Unknown
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.