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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00961-1
Product Name/Description Sorin S5/C5 Perfusion System: S5 Single Roller Pump 150 and S5 Double Roller Pump 85 (Heart-lung Bypass System)

S5 Single Roller Pump 150
Product Code: 10-80-00
Serial Number: 10E06300, 10E06301 and 10E06302

S5 Double Roller Pump 85
Product Code:10-85-00
Serial Number: 10E51883

ARTG Number: 108387
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 21/09/2012
Responsible Entity Cellplex Pty Ltd
Reason/Issue There have been reports received of a "fault in motor controller" alarm message. If this occurs, the pump stops, an audible alarm sounds and a visual alarm is displayed as "fault in motor controller" on the system panel. On some occasions the circuit breaker of the pump on the emergency power pack may also trip.
Recall Action Recall for Product Correction
Recall Action Instructions Cellplex is informing the hospitals to quarantine the roller pumps until the affected components have been replaced by Cellplex. Unaffected roller pumps will be supplied by Cellplex as loan units, if required
Contact Information 03 9799 7444 - Cellplex National Sales