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DCI Edge

DCI International, LLC · Model CP1000 · UDI-DI 00810021435916

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

Description

Pediatric Bench

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.