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U.S. Department of Health and Human Services

Class 2 Device Recall Decade Plus 1221 Dental Chair

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  Class 2 Device Recall Decade Plus 1221 Dental Chair see related information
Date Initiated by Firm April 01, 2009
Create Date June 25, 2015
Recall Status1 Terminated 3 on December 16, 2010
Recall Number Z-0541-2011
Recall Event ID 52039
510(K)Number K913535  
Product Classification chair, dental, with operative unit - Product Code KLC
Product A-dec Decade Plus 1221 Dental Chair

This chair is used for positioning dental patient prior to and during dental treatment.
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Recalling Firm/
Manufacturer		 A-Dec Inc
2601 Crestview Dr
Newberg OR 97132
For Additional Information Contact Customer Service
800-547-1883
Manufacturer Reason
for Recall		 The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.
FDA Determined
Cause 2		 Device Design
Action A-dec sent a letter dated March 23, 2009 to consignees/customers (doctors and network dealers). The consignees were informed that the design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests. The potential for this occurs when returning the chair to the upright position. The consignees were advised to reprogram the Position 0/Entry-Exit preset to stop the back before it reaches a full upright position. This increases the gap between the armrest and the back slightly. To reprogram a chair, the firm included excerpts from a chair Instructions for Use (IfU) guide that detail the steps to reprogram a chair. Consignees can contact the firm's Customer Service at 503-538-9471, 1-800-547-1883, or via fax at 503-538-0276. The firm will replace the chair back assembly for all affected dental chairs.
Quantity in Commerce 2723 units
Distribution Worldwide distribution: US and Canada.
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 = KLC and Original Applicant = A-DEC, INC.
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