Portable X-ray system recall
Portable X-ray system
Why was Portable X-ray system recalled?
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI/Model Name: 08800021800014/DIOX-602
- Product
- Portable X-ray system
- Recalling firm
- DIGIMED CO., LTD
- Quantity
- 530
- Distribution
- US
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)