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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