Lower riskMedical device recall · FDA · Published October 28, 2021
Palodex Orthopantomograph OP300 X-ray System Recall: Testing Error Risk
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%).
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Contact the company
📍Recalling firmPalodex Group OyNahkelantie 160 · Tuusula, Finland
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61622-palodex-orthopantomograph-op300-x-ray-system-recall-testing-error-risk.
“Palodex Orthopantomograph OP300 X-ray System Recall: Testing Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61622-palodex-orthopantomograph-op300-x-ray-system-recall-testing-error-risk. Based on FDA recall #Z-2413-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2024%22&limit=1).
The Food and Drug Administration announced on Oct. 28, 2021, that Palodex Group Oy is recalling Orthopantomograph OP300 dental computed tomography x-ray systems. The hazard involves a production error where the final testing database incorrectly reports a pass for Pan ADC repeatability tests even when results fall outside acceptance criteria.
How to tell if you have it
Brand: Palodex
Product: Orthopantomograph OP300 dental computed tomography x-ray system
DI codes: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Quantity: 103 units
The hazard
According to the FDA, the recall addresses a defect noticed in production on Oct. 28, 2021, where the final testing database gives a pass result for Pan ADC repeatability tests even when the test result is not within the set acceptance criteria of repeatability within 4%.
Context
GovInfoNow's records show Palodex Group Oy has one other recall on record since Jan. 7, 2020, involving a risk of fire from a PSU short circuit in Soredex DIGORA Optime X-Ray Imagers. Other recent recalls of similar products include GE Optima XR200amx Mobile Radiography System Recall (June 5, 2026), GE Optima XR220amx Mobile X-Ray System Recall (June 5, 2026), and Canon Alphenix X-ray Systems Recall (Aug. 4, 2026).
How to tell if you have this one
Check for serial numbers: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770. The device is used by qualified healthcare professionals for dental CT x-ray imaging.
Brand
Palodex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Look for the specific serial numbers listed in the recall notice: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide-Worldwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
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.
Official source: FDA Recall #Z-2413-2024 (October 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2413-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.