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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00258-1
Product Name/Description DASH, PDM and Tram models (Multiparameter patient monitor)

Manufactured between October 2010 and September 2012

Dash 3000/4000/5000
Product codes: SHQ and SD0

Patient Data Module (PDM)
Product code: SA3

Tram 451, 451N, 451M, 851, 851N, 451N5, 851N5
Product codes: RT1, RT4, RT5, RT7, RT8, RTW, SCE and SBB

ARTG Number: 92726
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/04/2013
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue ECG and Respiration signal noise caused by DASH, PDM and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
Recall Action Recall for Product Correction
Recall Action Instructions End users have been provided with work around instructions to help mitigate the issue. GE Healthcare is currently in discussion with TGA as how to best expedite identification of, and prioritised correction of affected units. A follow-up letter will be forwarded once there is a consensus as to the process to be undertaken. This action has been closed-out on 12/02/2016.
Contact Information 1300 722 229 - GE National Service and Support Centre