Tuesday, April 13, 2010

FDA: Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair

 Class 3 Recall
Pelton & Crane Pelton & Crane Spirit 3000 Dental Chair
Date Posted April 09, 2010
Recall Number Z-1311-2010
Product Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positioning patients to perform dental procedures.
Code Information Catalog number: 3003, Model number: SP30, Chair Serial #14736
Recalling Firm/
Manufacturer
Pelton & Crane Company
11727 Fruehauf Dr
Charlotte, North Carolina 28273
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Frank Ray
704-588-2126 Ext. 227
Reason for
Recall
The Dental Chair lacks a valid Device History Record.
Action An "URGENT MEDICAL DEVICE RECALL" letter dated February 9, 2010, was delivered in person to the customer. The letter describe the product, problem and action to be taken by the customer. The customer was requested to provide the name and location of the consignee who received the chair so that Pelton & Crane can contact the end user to arrange to replace the affected chair with a new dental chair, and to complete the enclosed Recall Acknowledgement/Return Form and fax to (704) 587-7204. A monthly status report will be submitted to FDA. Please contact Pelton & Crane Customer Care at 1-800-659-6560 or call Mr. Frank Ray directly at 704-587-7227 to let us know where the device is currently stored.
Quantity in Commerce 1 unit
Distribution Nationwide distribution: NC

No comments: