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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01291-1
Product Name/Description	Philips M1783A and M5526A 12 Pin Sync Cables ARTG Number: 95661
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	10/12/2014
Responsible Entity	Philips Electronics Australia Ltd
Reason/Issue	The following problems were found during internal testing: If Electrical Fast Transits (EFT) noise is injected into the monitor/defibrillator via AC mains power, and the monitor/defibrillator is connected to and receiving ECG signals from an auxiliary bedside monitor with an M1783A/M5526A 12 pin Sync Cable (8/24 feet) via the monitor’s ECG Out port, then: 1. When using a sync cable with the HeartStart MRx or HeartStart XL, EFT noise can be mistaken as an R-wave. If this occurs when performing synchronized cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronized to EFT noise instead of the patient’s actual R-wave. 2. When using a sync cable with the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing, leading to a possible delay in therapy. A power cycle is required to resume ECG monitoring, however, fixed mode pacing is not impacted by this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Philips will replace all affected sync cables with a new sync cable free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for a replacement. This action has been closed-out on 05/12/2016.
Contact Information	1800 251 400 - Philips Customer Care Centre