Portable X-ray system recallZ-2117-2025 · Digimed CO., Ltd · initiated Jun 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Digimed CO., Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
FDA root cause category: Radiation Control for Health and Safety Act
What the company is doing
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.
Recall details
- Recall number
- Z-2117-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 19, 2025
- Posted by the FDA
- Jul 18, 2025
- Recalling firm
- Digimed CO., Ltd
- Quantity
- 530
- Product code
- EHD
- FDA submissions
- K082167
- Distribution
- US
Product description
Portable X-ray system
Code information (models, lots, serial numbers)
UDI-DI/Model Name: 08800021800014/DIOX-602
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DIOX-602 1DigiMed Co., Ltd. · Unit, X-Ray, Extraoral With Timer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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