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E100 series(E1-M, E1-C, E1-W)

DENTIS CO. ,LTD · Model E1-W · UDI-DI 08800053060769

KZF Prescription
10
510(k) clearances
401
Adverse events
5
Recalls
92
Facilities

Description

INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33

Recalls

DateFirmReason
2025-10-13MRIMed Inc.Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
2017-04-21Stryker CommunicationsThe exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be in
2016-11-18Ohmeda MedicalCertain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord
2013-07-25Stryker CommunicationsPotential incomplete final weld on the drop tube flange.
2004-02-19Burton Medical Products CorpPivot joint on these ceiling mount lights may fail and lights may fall onto patients.

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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.