Z-1248-2011

Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1...

Name: Z-1248-2011 Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1...
Creator: Gendex Dental Systems
Published: 2010-12-17
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2010-12-17 / Terminated / root cause: design

FDA source

Gendex Dental Systems began a recall of Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA on 2010-12-17. The reason FDA records is "The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1248-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-02-15
Terminated: 2011-02-15
Recalling firm: Gendex Corp.
Product: Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.
Root cause tag: design
FDA root cause: Component design/selection
Action: Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction.
Quantity in commerce: 5 units
Distribution: California
Product codes and lots: Model 110-0205G1, catalog number EXPERTDC75NA; serial numbers 1987591 - 09/2010, 1987597 - 09/2010, 1987598 - 09/2010, 1987599 - 09/2010 and 1987600 - 09/2010

Product code EHD

K992610Class IIGendex 765Dc, Model 110-0154Dentsply Intl. / cleared 1999-09-07

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)