Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

cone-beam CT system

FDA Recall Z-1101-2019 · Posted None

Recalling FirmKaVo Dental Technologies LLC
Recall StatusOpen, Classified
Product CodeOAS
Date Initiated2018-12-31
Product Quantity230

Reason for Recall

ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

Firm 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.

Root Cause

Device Design

Distribution Pattern

US distribution in NC

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180947Orthopantomograph OP 3DPalodex Group OY · 2018-06-07K170813ORTHOPANTOMOGRAPH OP 3DPalodex Group OY · 2017-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑