Omnitex U
OMNIA SRL · Model 30.Z0010.00 · UDI-DI 08056646506286
0
510(k) clearances
33
Adverse events
4
Recalls
109
Facilities
Description
Universal sheath Omnitex U - green - nitrile
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 |
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Get your free API keyRead the docsData 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.