U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
chair, dental, with operative unit - Product Code KLC
원인
The design of the decade plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.
조치
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.