Z-1325-2010

Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273...

Name: Z-1325-2010 Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273...
Creator: Pelton & Crane Company
Published: 2010-02-24
License: https://open.fda.gov/license/

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

FDA source

Pelton & Crane Company began a recall of Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to... on 2010-02-24. The reason FDA records is "Magnetic headrests may affect patients with implantable pacemakers and defibrillators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1325-2010
Status: Terminated
Initiated: 2010-02-24
Posted: 2010-04-01
Terminated: 2010-10-28
Recalling firm: KaVo Dental Technologies, LLC
Product: Pelton & Crane Dental Chairs, Spirit 2000 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 SP20

Product code KLC

K760404Class IBi-Centric SystemPelton & Crane Co. / cleared 1976-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)