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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = EHD
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