Z-0009-2015Class II

eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN...

Name: Z-0009-2015 eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN...
Creator: Gendex Corp
Published: 2014-08-12
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2014-08-12 / Terminated / root cause: manufacturing process

FDA source

Gendex Corp began a recall of eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach... on 2014-08-12. FDA classified it as Class II and gives the reason as "Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube...". 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-0009-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-12
Posted: 2014-10-02
Terminated: 2017-03-24
Recalling firm: Gendex Corp.
Product: eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029.
Quantity in commerce: 651
Distribution: Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand.
Product codes and lots: Models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC; with multiple part numbers and serial numbers: see distribution list for these details.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-10-02

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)