Dash 3000 Patient Monitor

• • Ongoing Z-0519-2019 FDA Class II ·initiated 31 Aug 2018 ·on shared 510(k) K992929

  The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

• • Terminated Z-0982-2014 FDA Class II ·initiated 27 Nov 2013

  GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network. 4.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K992929 ↗

FDA Product Code

MHX

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Case 8000 Exercise Testing System

  Not classified

  FDA 510(k) K991014 Active Cleared 20 Oct 1999

• Solar 7/8000

  Class II

  FDA 510(k) K993757 Active Cleared 23 Mar 2000

• Bis/EEG Module

  Class II

  FDA 510(k) K012466 Active Cleared 1 Oct 2001

• Solar 8000M System Open recall

  Class II

  FDA 510(k) K012467 Active Cleared 11 Feb 2002

• Dash 3000/4000 Patient Monitor Open recall

  Class II

  FDA 510(k) K001359 Active Cleared 18 Jul 2000

• Corometrics Model 171 and 172 Fetal Monitor

  Class II

  FDA 510(k) K991905 Active Cleared 1 Sep 1999

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