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Terminated

Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273. Intended for the properly positioning of patients to perform dental procedures.

FDA Recall Z-1324-2010 · Posted 2010-04-01

Recalling FirmPelton & Crane Company
Recall StatusTerminated
Product CodeKLC
Date Initiated2010-02-24
Date Terminated2010-10-28
Product QuantityTotal: 498 chairs and 619 replacement upholstery spare parts

Reason for Recall

Magnetic headrests may affect patients with implantable pacemakers and defibrillators.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- United States, Australia, the Netherlands, Canada and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K760404BI-CENTRIC SYSTEMPelton & Crane Co. · 1976-08-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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