Palodex Group Oy is recalling 103 Orthopantomograph OP300 dental computed tomography (CT) x-ray systems because of a software or database error during production testing. It was discovered that the testing database was incorrectly recording a 'pass' for image repeatability even when the device failed to meet the required 4% accuracy threshold. This defect means that affected x-ray machines may not produce consistent or accurate 2D and 3D dental images, which could impact patient diagnosis and treatment planning by qualified healthcare professionals.
If the x-ray system does not meet repeatability standards, healthcare providers may receive inconsistent imaging results, potentially leading to misdiagnosis or the need for repeat x-ray exposure for the patient. While no injuries have been reported, the device fails to meet the manufacturer's own set safety and performance acceptance criteria.
Manufacturer Notification and Device Verification
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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