Spacelabs Smart Disclosure System

• • Terminated Z-2035-2019 FDA Class II ·initiated 28 Jan 2019

  Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

• • Terminated Z-1273-2014 FDA Class II ·initiated 14 Feb 2014

  Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Access.

• • Terminated Z-0694-2013 FDA Class II ·initiated 5 Dec 2012

  Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of Smart Disclosure, Model 92810.

510(k) Number

K110779 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• elance Vital Signs Monitor, Central Monitor Software

  Class II

  FDA 510(k) K150329 Active Cleared 5 Nov 2015

• Spacelabs Arkon Anesthesia Workstation

  Class II

  FDA 510(k) K113051 Active Cleared 22 Mar 2012

• Speacelabs Multigas Module

  Class II

  FDA 510(k) K112173 Active Cleared 5 Oct 2011

• Capnography Pad (92516)

  Class II

  FDA 510(k) K121017 Active Cleared 13 Jul 2012

• Spacelabs Healthcare Telemetry Receiver Open recall

  Class II

  FDA 510(k) K141156 Active Cleared 9 Sep 2014

• BLEASE700/900 Series Ventilators

  Class II

  FDA 510(k) K112729 Active Cleared 11 Jun 2012

See all devices from Spacelabs Healthcare Inc. →