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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00710-3
Product Name/Description Alaris PC Unit (General purpose infusion pump)

Model Number: 8015

PC units manufactured or serviced after January 2011 that contain PC Unit power supply board: P/N TC10005122

Multiple serial numbers affected

ARTG Number: 146664
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/07/2012
Responsible Entity CareFusion Australia 316 Pty Ltd
Reason/Issue The manufacturer has identified a potential risk associated with a component on the PC unit power supply board which is causing an error code (120, 4630) "System Error" or "Missing Battery Error" at start up or prevent programming changes if the problem occurs during use.
Recall Action Recall for Product Correction
Recall Action Instructions If error observed remove PC unit from use. PC Unit boards replaced.
Contact Information 02 9624 9006 - Melissa Robins