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Tubing cover sleeve

OMNIA SRL · Model 12.U0022.00 · UDI-DI 08056646509959

NRU Prescription
0
510(k) clearances
33
Adverse events
4
Recalls
109
Facilities

Description

Tubing cover sleeve

Recalls

DateFirmReason
2011-03-04Pelton & Crane CompanyThe Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
2011-03-04Pelton & Crane CompanyThe Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.
2011-03-01Dental Equipment LLCLink arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
2010-03-23Dental Equipment LLCThe magnetic headrest on certain dental chairs may affect the function/programming of some implantable pacemakers or defibrillators if the implanted device is programmed to respond

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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.