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UMF Medical

UNITED METAL FABRICATORS, INC. · Model 4011-650-301B · UDI-DI 00815235020941

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

UMF Medical ProGlide4011 Procedure Chair-BASE ONLY w/ OneTouch WheelBase® System for infection prevention, patient & staff safety-allows Chairs to be easily moved to clean room & flex space, ADA access,650lb patient wt capacity, elec receptacle & OneTouch Patient Positioning® System w/Return-to-Home Hand & Foot Controls programmable allow clinician to customize patient position efficiently. Stirrups, articulating headrest for flexible use in office procedures and unparalleled patient comfort.Best-in-Class seamless, removable upholstery w/ PreFixx® Protective Finish to assist w/ Infection Prevention. Upholstered Top sold separate and available in 16 Colors.- 220v

Recalls

Date	Firm	Reason
2016-06-29	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver.
2009-01-26	Phillips Nuclear Medicine	A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were

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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.