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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.