Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrestsee related information
Date Initiated by FirmFebruary 24, 2010
Date PostedApril 01, 2010
Recall Status1 Terminated 3 on October 28, 2010
Recall NumberZ-1324-2010
Recall Event ID 54719
510(K)NumberK760404 
Product Classification Chair, dental, with operative unit - Product Code KLC
ProductPelton & Crane Dental Chairs, Spirit 1800 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 SP18
Recalling Firm/
Manufacturer		 Pelton & Crane Company
11727 Fruehauf Dr
Charlotte NC 28273
For Additional Information ContactMr. 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
ActionPelton & 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 CommerceTotal: 498 chairs and 619 replacement upholstery spare parts
DistributionWorldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KLC
-
-