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Terminated

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

FDA Recall Z-0541-2011 · Posted None

Recalling FirmA-Dec Inc
Recall StatusTerminated
Product CodeKLC
Date Initiated2009-04-01
Date Terminated2010-12-16
Product Quantity2723 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US and Canada.

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.

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