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U.S. Department of Health and Human Services

Class 2 Device Recall Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest

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  Class 2 Device Recall Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest see related information
Date Initiated by Firm February 24, 2010
Date Posted April 01, 2010
Recall Status1 Terminated 3 on October 28, 2010
Recall Number Z-1326-2010
Recall Event ID 54719
510(K)Number K760404  
Product Classification Chair, dental, with operative unit - Product Code KLC
Product Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.

Intended for the properly positioning of patients to perform dental procedures.
Code Information All Devices with Model Number SP30
Recalling Firm/
Manufacturer		 Pelton & Crane Company
11727 Fruehauf Dr
Charlotte NC 28273
For Additional Information Contact Mr. Frank Ray
704-588-2126 Ext. 227
Manufacturer Reason
for Recall		 Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
FDA Determined
Cause 2		 Device Design
Action Pelton & Crane Issued an "Urgent Field Safety Alert" notification dated February 24, 2010. Consignees were instructed of the affected product and informed of proper actions to take. For further information, contact Pelton & Crane at 1-704-588-2126.
Quantity in Commerce Total: 498 chairs and 619 replacement upholstery spare parts
Distribution Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.
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 = PELTON & CRANE CO.
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