Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1179-2010

Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273...

KaVo Dental Technologies, LLC / initiated 2010-02-24 / Terminated / root cause: design

Pelton & Crane Company began a recall of Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to... on . The reason FDA records is "Magnetic headrests may affect patients with implantable pacemakers and defibrillators". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1179-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
KaVo Dental Technologies, LLC
Product
Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.
Product code
KLC Chair, Dental, With Operative Unit
Reason for recall
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
Root cause tag
design
FDA root cause
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.
Product codes and lots
All Devices with Model Number L5