Reported Aug 21, 2024 · Ongoing
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images…
Palodex Group Oy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Palodex Group Oy · Nahkelantie 160 · Tuusula · N/A
Is this the product you have?
- Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
- Lot codes and dates
- DI
064300358727250643003587273206430035872749064300358727560643003587276306430035872770
- DI
- Amount recalled
- 103
Where it was sold
- Nationwide
Why it was recalled
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%).
This product could cause temporary or reversible health problems — stop using it.
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