ORTHOPANTOMOGRAPH OP 3D Pro OP300-1 (REF 901004)Recalls & reported problems
PaloDEx Group Oy · Class 2
All models of ORTHOPANTOMOGRAPH OP 3D Pro (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Oct 28, 2021Class IIOpen, Classified
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%).
Z-2413-2024 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗
Other X-Ray, Tomography, Computed, Dental devices
- T2 T2-CSOsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- T2 Plus T2-CS-POsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- T1-CSOsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- T1-COsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- T2 T2-COsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- T2 Plus T2-C-POsstem Implant Co.,Ltd. · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
- ORTHOPANTOMOGRAPH OP 3D Pro OP300-1PaloDEx Group Oy · X-Ray, Tomography, Computed, Dental1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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