DIGIMED CO., LTD is recalling 530 units of the DIOX-602 Portable X-ray system because they do not meet the minimum source-to-skin distance (SSD) requirement of 18 cm. This recall affects units currently in use within the United States. Users should contact the manufacturer or their distributor immediately to arrange for the equipment to be corrected or returned.
If the source-to-skin distance is less than the required 18 cm, the patient may receive a higher dose of radiation to their skin and surface tissues during dental imaging than safety standards allow.
Quantity affected: 530 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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