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.
FDA Recall Z-1559-2011 · Posted 2011-03-04
Recalling FirmGendex Dental Systems
Recall StatusTerminated
Product CodeEHD
Date Initiated2010-12-20
Date Terminated2012-08-14
Product Quantity34 wall plates
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.
Firm 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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA and countries including: Australia, Canada and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.