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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOPANTOMOGRAPH OP 3D CBCT xray systems.

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  Class 2 Device Recall ORTHOPANTOMOGRAPH OP 3D CBCT xray systems. see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = OAS and Original Applicant = PaloDEx Group Oy
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