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U.S. Department of Health and Human Services

Class 2 Device Recall Wall Mounting Plate

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  Class 2 Device Recall Wall Mounting Plate see related information
Date Initiated by Firm December 20, 2010
Date Posted March 04, 2011
Recall Status1 Terminated 3 on August 14, 2012
Recall Number Z-1559-2011
Recall Event ID 57500
510(K)Number K992610  
Product Classification Unit, x-ray, extraoral with timer - Product Code EHD
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.
Code Information part numbers D800WPEXPERT, D800WP, EXPERTDC55 NAWP, EXPERTDC65 NAWP and EXPERTDC75 NAWP distributed between April 12, 2010 and May 13, 2010
Recalling Firm/
Manufacturer		 Gendex Dental Systems
901 W Oakton St
Des Plaines IL 60018-1843
For Additional Information Contact Ms. Elizabeth Lazaro
267-954-0365
Manufacturer 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.
FDA Determined
Cause 2		 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: regulatory.affairs@gendex.com 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 regulatory.affairs@gendex.com.
Quantity in Commerce 34 wall plates
Distribution Worldwide distribution: USA and countries including: Australia, Canada and Germany.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EHD and Original Applicant = DENTSPLY INTL.
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