Reported Jul 30, 2025 · Ongoing
Portable X-ray system
Digimed Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DIGIMED CO., LTD · 401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu · Seoul, N/A · N/A
Is this the product you have?
- Portable X-ray system
- Lot codes and dates
- UDI-DI/Model Name08800021800014/DIOX-602
- Amount recalled
- 530
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.
This product could cause temporary or reversible health problems — stop using it.
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