Z-1265-2009

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

Name: Z-1265-2009 Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging...
Creator: Imaging Sciences International, LLC
Published: 2009-01-08
License: https://open.fda.gov/license/

Dental Imaging Technologies Corporation / initiated 2009-01-08 / Terminated / root cause: manufacturing process

FDA source

Imaging Sciences International, LLC began a recall of Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation on 2009-01-08. The reason FDA records is "faulty calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1265-2009
Status: Terminated
Initiated: 2009-01-08
Posted: 2009-05-22
Terminated: 2009-06-04
Recalling firm: Dental Imaging Technologies Corporation
Product: Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
Product code: MUH System, X-Ray, Extraoral Source, Digital
Reason for recall: faulty calibration
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 24 units
Distribution: Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
Product codes and lots: Model number: G1-15-1-0; Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291.

Product code MUH

K061284Class III-Cat ScannerImaging Sciences Intl., Inc. / cleared 2006-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)