Digimed DIOX-602 Portable X-ray System Recall: SSD Too Small

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Recalling firmDIGIMED CO., LTD401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu, N/A · Seoul, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Digimed is recalling portable X-ray systems with model DIO:0X-602 because they don't meet the minimum safety distance requirement of 18 cm. This could lead to safety risks if used improperly.

Why it’s dangerous

The X-ray system requires a minimum safety distance (SSD) of 18 cm to prevent radiation exposure. If the SSD is smaller than this, it could increase the risk of radiation exposure to users or patients.

Who’s affected

Healthcare facilities and medical professionals using Digimed DIOX-602 portable X-ray systems in the U.S. are most at risk due to potential safety issues.

How to tell if you have this one

Check for the model number DIOX-602 on the device. The product was sold in the U.S. with the UDI-DI: 08800021800014.

Brand
Digimed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Safety Distance
Measure the safety distance (SSD) between the X-ray source and the patient. If it's less than 18 cm, the unit is affected.

✎ GovInfoNow

Questions people ask

Why is this X-ray system being recalled?

The DIOX-602 units do not meet the minimum safety distance (SSD) requirement of 18 cm, which could increase radiation exposure risk.

How can I tell if my X-ray system is affected?

Look for the model number DIOX-602 on the device. The product was sold in the U.S. with the UDI-DI: 08800021800014.

What should I do if I have this X-ray system?

Check the safety distance (SSD) between the X-ray source and the patient. If it's less than 18 cm, contact Digimed for guidance.

Take action

Contact Digimed

We’ve drafted a message you can send Digimed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2117-2025 — Digimed Digimed

Hello,

I own a Digimed that is covered by recall Z-2117-2025 from Digimed.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2117-2025 (June 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2117-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

DIGIMED CO., LTD recalls Portable X-ray system

Use caution until it’s fixed