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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00877-1
Product Name/Description Spacelabs Healthcare Integrated Module Housing (Used for accommodating additional modules to the patient monitor whenever needed)

Model Number: 91493

ARTG Number: 128789
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/08/2012
Responsible Entity Medtel Pty Ltd
Reason/Issue There is a potential failure of the Integrated Module Housing; causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
Recall Action Recall for Product Correction
Recall Action Instructions Medtel is providing work around instructions to users to mitigate the issue until a permanent fix can be installed.
Contact Information 03 8564 0806 - Medtel Regulatory Affairs