FDA Recall Terminated

A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

Recall: Z-0541-2011 · Initiated April 1, 2009

Recall

Recall Number
Z-0541-2011
Event Number
52039
Firm
A-Dec Inc
FEI Number
3015729
Product Code
KLC
Status
Terminated
Root Cause
Device Design
Initiated
April 1, 2009
Terminated
December 16, 2010
Address
2601 Crestview Dr, Newberg, OR, 97132

Description

A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

Reason

The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.

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.

Distribution

Worldwide distribution: US and Canada.

Quantity

2723 units