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Terminated

Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

FDA Recall Z-1265-2009 · Posted 2009-05-22

Recalling FirmImaging Sciences International, LLC
Recall StatusTerminated
Product CodeMUH
Date Initiated2009-01-08
Date Terminated2009-06-04
Product Quantity24 units

Reason for Recall

faulty calibration

Firm Action

Imaging Sciences International issued a letter to Customers dated January 7, 2009 informing them of the affected device. Users were advised to discontinue use of the device until they are contacted by a service representative and a certified re-calibration of the device is performed. Users were also asked to return a completed "Acknowledgement Form" by fax to the firm at 1-215-997-5665. Additional questions can be made to Imaging Sciences International by calling 1-800-205-3570 Extension 299.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061284I-CAT SCANNERImaging Sciences Intl., Inc. · 2006-07-03

Official Source

View FDA Recall →

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

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