HMEClass I

Chair, Ophthalmic, Ac-powered

Ophthalmic · 21 CFR 886.1140

MDR events11All time

Recalls1All time

Registered firms34Currently listed

510(k) clearances16All time

Recent MDR events

11 adverse event reports on file

500 XLE OPHTHALMIC SURGERY EYE CHAIROct 7, 2024
MalfunctionUfsk-international Osys Gmbh20383801
ENCORE AUTOMATIC EXAM CHAIRJan 26, 2022
InjuryMarco / Takagi Seiko Co., Ltd.MW5107016
RELIANCE MEDICAL PRODUCTS, INCMay 13, 2019
MalfunctionReliance Medical Products, Inc.1523545-2019-00001
RELIANCE MEDICAL PRODUCTS FX920 LOW VOLTAGE CONTROL CHAIRSep 25, 2017
MalfunctionReliance Medical Products, Inc.1523545-2017-00001
RELIANCE MODEL DMI 230Jan 11, 2011
Malfunction1523545-2011-00001
DMI RELIANCE MODEL 230 DMINov 23, 2010
MalfunctionReliance Medical Product, Inc.1928870
ULTIPOR 100Nov 20, 2008
InjuryPall Life SciencesMW5009063
S2800 SERIES MAXI-CHAIRMar 6, 2008
MalfunctionGlobal Surgical Corp.1937051-2008-00001
REICHERTNov 5, 2005
MalfunctionReichert Ophthalmic Instruments646973
REICHERT/CAMBRIDGEAug 1, 2005
MalfunctionReichert Opthalmic Instruments627323

Event type breakdown

Malfunction8

Injury2

Unspecified1

Most-reported manufacturers

Reliance Medical Products, Inc.3 Reichert Ophthalmic Instruments2 Unspecified1 Global Surgical Corp.1 Marco / Takagi Seiko Co., Ltd.1 Pall Life Sciences1 Reichert Opthalmic Instruments1 Reliance Medical Product, Inc.1

Recalls

1 recall events for this product code

UFSK - International OSYS Gmbh
Open, ClassifiedJul 20, 2023
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term
Service life of the electrical seat part drive of the treatment chair may be shortened unexpectedly after several years of use due to a potential wear-related reduction in the self-locking of the drive and may remain undetected. A worsened self-locking of the seat drive can lead to overriding the drive s end position when positioning the patient with the seat part in an inclined position
Z-2212-2023 · View FDA record ↗

Registered firms

34 firms currently registered for this product code

510(k) clearances

16 clearances for this product code