Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag
Summary
The FDA issued a Class II for Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray de by Palodex Group Oy. Reason: 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 resu.
Details
Source
Device Recall
External ID
Z-2413-2024
Action Date
2024-08-21
Status
Ongoing
Category
device
Product Description
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/Code Info: DI: 06430035872725, 06430035872732, 06430035872749, 06430035872756, 06430035872763, 06430035872770
Quantity Affected: 103
Reason for Recall
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%).
Distribution
US Nationwide-Worldwide
Type: FDA Mandated
Recall Initiated: 2021-10-28
Company
Tuusula
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Palodex Group Oy has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Palodex Group Oy) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Palodex Group Oy have FDA actions?
Palodex Group Oy has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2413-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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