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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-00721-1
Product Name/Description	All CARESCAPE Central Station V2 units GTIN: 00840682109666 and 00840682109604 ARTG 132673 (GE Medical Systems Australia Pty Ltd - Patient monitor, central unit)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/05/2022
Responsible Entity	GE Healthcare Australia Pty Ltd
Reason/Issue	GE Medical Systems Australia advise that the CARESCAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected. Loss of monitoring can result in delayed response to a change in patient clinical condition. To date, there have been no injuries reported as a result of this issue.
Recall Action	Product Defect Correction
Recall Action Instructions	GE Medical Systems Australia ask customers to: 1. Continue to use the CSCS V2 to monitor patients on the CARESCAPE Network. 2. If there is a loss of patient monitoring at the CSCS V2, follow the detailed description of safety instructions outlined in the Customer letter.
Contact Information	1-800-659-465 - GE Healthcare Service