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Planmeca Chair

Planmeca Oy · Model Chair · UDI-DI 06430035420162

KLC
10
510(k) clearances
42
Adverse events
7
Recalls
16
Facilities

Description

Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to left and right. The chair has an integrated foot control for automatic chair positions and manual movements. The chair can be equipped with optional foldable knee-break.

Recalls

DateFirmReason
2010-02-24Pelton & Crane CompanyMagnetic headrests may affect patients with implantable pacemakers and defibrillators.
2010-02-24Pelton & Crane CompanyMagnetic headrests may affect patients with implantable pacemakers and defibrillators.
2010-02-24Pelton & Crane CompanyMagnetic headrests may affect patients with implantable pacemakers and defibrillators.
2010-02-24Pelton & Crane CompanyMagnetic headrests may affect patients with implantable pacemakers and defibrillators.
2010-02-24Pelton & Crane CompanyMagnetic headrests may affect patients with implantable pacemakers and defibrillators.
2010-02-09Pelton & Crane CompanyThe Dental Chair lacks a valid Device History Record.
2009-04-01A-Dec IncThe design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.