| Class 2 Device Recall ORTHOPANTOMOGRAPH OP 3D CBCT xray systems. |  |
Date Initiated by Firm | December 31, 2018 |
Create Date | April 22, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1101-2019 |
Recall Event ID |
82045 |
510(K)Number | K170813 K180947 |
Product Classification |
X-ray, tomography, computed, dental - Product Code OAS
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Product | cone-beam CT system |
Code Information |
versions 2.1.0 and 2.1.1 |
Recalling Firm/ Manufacturer |
KaVo Dental Technologies LLC 11727 Fruehauf Dr Charlotte NC 28273-6507
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For Additional Information Contact | 704-588-2126 |
Manufacturer Reason for Recall | ORTHOPANTOMOGRAPH OP 3D device has a
defect in the device firmware versions 2.1.0 and 2.1.1 |
FDA Determined Cause 2 | Device Design |
Action | Palodex Group Oy sent a Notification letter to affected customers on or about December 31, 2018. The letter identified the affected product, problem and actions to be taken. The firm corrective action is to update the firmware of ORTHOPANTOMOGRAPH OP 3D of the defective units. Acknowledgement to the field correction letter is requested within 30 days from receiving the letter. |
Quantity in Commerce | 230 |
Distribution | US distribution in NC |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = OAS
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