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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00855-1
Product Name/Description SLE 5000 Ventilator

Ventilator model SLE 5000: Serial numbers below 53164

Power supply unit model FP110-410: Serial numbers 163746 to 167558 inclusive

ARTG Number: 114000
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/08/2013
Responsible Entity AHC Solutions Pty Ltd
Reason/Issue The manufacturer has identified a potential risk associated with the FP110-410 PSU (Power Supply Unit). Their internal monitoring and investigations have identified a suspect batch of electrolytic capacitors used on the main PCB (printed circuit board) of the 410 power supply unit. The affected capacitors may exhibit a swelling that if not replaced, may in time cause the ventilator to shut down during normal operation. Please note that should the ventilator shut down, a total power fail alarm will sound.
Recall Action Recall for Product Correction
Recall Action Instructions AHC Solutions is advising users to identify ventilators with serial numbers below 53164 and, using the instructions provided, identify ventilators with Power Supply Units with serial numbers between 163746 to 167558 for replacement.
Contact Information 02 9980 9669 - AHC Solutions