Home › OMNIA SRL › Universal seat cover and backrest cover Shell Cover

Universal seat cover and backrest cover Shell Cover

OMNIA SRL · Model 20.O0105.00 · UDI-DI 08056646505883

NRU

510(k) clearances

Adverse events

Recalls

109

Facilities

Description

Universal seat cover and backrest cover Shell Cover

Recalls

Date	Firm	Reason
2011-03-04	Pelton & Crane Company	The 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.
2011-03-04	Pelton & Crane Company	The 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.
2011-03-01	Dental Equipment LLC	Link arm assembly that mounts the rear mounted accessories to the dental chair may potentially break and fall off the dental chair.
2010-03-23	Dental Equipment LLC	The 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.