Spacelabs Medical Integrated Clinical Display

• • Terminated Z-0288-2011 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009

  The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment.

• • Terminated Z-0620-2011 FDA Unclassified (pre-2012) ·initiated 20 Mar 2009

  The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.

• • Terminated Z-0422-05 FDA Unclassified (pre-2012) ·initiated 7 Jan 2005

  Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.

• • Terminated Z-0269-04 FDA Unclassified (pre-2012) ·initiated 29 Oct 2003

  Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.

510(k) Number

K932724 ↗

FDA Product Code

DXJ

Device Class

Class II

Regulation

21 CFR Part 870.2450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →