Palodex recalls Orthopantomograph OP300 dental CT x-ray systems due to a production testing error that may allow unsafe X-ray images. Affected units have specific serial numbers.
It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).
Palodex is recalling its Orthopantomograph OP300 dental CT x-ray systems because a production testing error could result in X-ray images that don't meet safety standards. This affects healthcare professionals using the device and may lead to unsafe imaging if the system is not properly calibrated.
The production testing database passed the Pan ADC repeatability test even when the results were outside the required 4% tolerance. This means the device might produce X-ray images that don't meet safety standards, but it does not cause immediate harm in normal use.
Healthcare professionals who own or use the Orthopantomograph OP300 dental CT x-ray systems are affected. The risk is low as the issue is a production testing error, not a safety hazard in normal use.
Check for serial numbers: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770. The device is used by qualified healthcare professionals for dental CT x-ray imaging.
Look for the specific serial numbers listed in the recall notice: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770.
The recall is due to a production testing error where the device passed a repeatability test even when the results were outside the required 4% tolerance, potentially leading to unsafe X-ray images.
Check if your device has one of the listed serial numbers. If it does, contact Palodex for further instructions.
The recall indicates a potential issue with X-ray image quality, but it does not describe any risk of injury in normal use. The hazard level is low risk.
We’ve drafted a message you can send Palodex to request your refund or repair — edit it as you like.
Subject: Recall Z-2413-2024 — Palodex Palodex Hello, I own a Palodex that is covered by recall Z-2413-2024 from Palodex. 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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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.
