Dental X-Ray Device Testing Defect May Affect Image Repeatability
Palodex Group Oy recalls the Orthopantomograph OP300 dental x-ray system due to a testing software defect that may allow devices with poor image repeatability to be distributed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a quality control defect in medical device testing software. No illnesses or injuries have been reported. The defect could allow devices that do not meet image repeatability specifications to reach clinical use, posing a risk of diagnostic error.
Plain-English summary
Palodex Group Oy has recalled the Orthopantomograph OP300, a dental computed tomography x-ray system used by qualified healthcare professionals. The system produces conventional 2D X-ray images and reconstructions for 3D diagnostic viewing.
The recall addresses a defect in the device's final testing procedure. The testing database software provides a pass result for the Pan ADC repeatability test even when the actual test result does not meet the established acceptance criteria of 4% repeatability. This defect, identified in production on October 28, 2021, means that some units may not meet required image repeatability specifications.
Approximately 103 units were affected, distributed under device identifiers DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, and 06430035872770.
Healthcare facilities that operate the Orthopantomograph OP300 should contact Palodex Group Oy or the FDA for information regarding this recall.
The recalled product
- Product
- 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.
- Manufacturer
- Palodex Group Oy
- Category
- Medical Device — Dental Imaging
- Hazard
- quality-control-defect
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- DI: 06430035872725
- 06430035872732
- 06430035872749
- 06430035872756
- 06430035872763
- 06430035872770
Distribution
Distributed nationwide across the United States.
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