OSSTEM Implant Co., Ltd. is initiating a correction for its T1, T2, and T2Plus Dental X-Ray Systems because the labeling may be missing a mandatory FDA certification statement. This statement is required for electronic products to confirm they meet federal radiation safety performance standards. The correction affects multiple models including T1-C, T1-CS, T2-C, T2-CS, T2-C-P, and T2-CS-P.
While the physical device may function normally, the missing certification statement means users cannot confirm the equipment complies with the U.S. Food and Drug Administration's radiological health regulations for electronic products.
Recall number Z-0313-2026.
Recall number Z-0314-2026.
Recall number Z-0315-2026.
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.
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Sources: FDA iRES · Raw API Response
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