Z-1559-2011

Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF...

Name: Z-1559-2011 Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF...
Creator: Gendex Dental Systems
Published: 2010-12-20
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2010-12-20 / Terminated / root cause: manufacturing process

FDA source

Gendex Dental Systems began a recall of Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des... on 2010-12-20. The reason FDA records is "The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate". 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-1559-2011
Status: Terminated
Initiated: 2010-12-20
Posted: 2011-03-04
Terminated: 2012-08-14
Recalling firm: Gendex Corp.
Product: Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
Product code: EHD Unit, X-Ray, Extraoral With Timer
Reason for recall: The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form via fax to 215-997-5665 Attn: Regulatory Affairs or email to: [email protected] and contact Gendex Customer Service at 1-800-323-8029. If you have any questions or concerns, contact the Regulatory Affairs Associate at 847-364-3290 or [email protected].
Quantity in commerce: 34 wall plates
Distribution: Worldwide distribution: USA and countries including: Australia, Canada and Germany.
Product codes and lots: part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP distributed between April 12, 2010 and May 13, 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)