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DIOX-602 1Recalls & reported problems

DigiMed Co., Ltd. · The DIOX-602 is a hand-held diagnostic dental x-ray system. It is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source producing diagnostic X-ray images using with intra-oral image receptors. Its use is intended for adults and pediatric subjects both. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The system helps to get sharp and clear x-ray images, and its low radiation dosage keeps patients and dentists safe from leakage radiation. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 19, 2025Open, Classified

    Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

    Z-2117-2025 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

Other Unit, X-Ray, Extraoral With Timer devices

All Unit, X-Ray, Extraoral With Timer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.