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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00520-1
Product Name/Description	Olympic Brainz Monitor (OBM) OBM Main Unit V3.1.5 Part number: OBM00401 UDI: 00382830010924 OBM Main Unit Part number: OBM00001 UDI: 00382830010818 OBM Reference Manual EN Part number: 027050 ARTG 166465 cancelled
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	26/06/2024
Responsible Entity	Paragon Healthcare Pty Ltd
Reason/Issue	The Olympic Brainz Monitor (OBM), reference Manual EN (027050 Rev 06), does not include instructions to conduct an electrical safety test on the medical device, which is in breach of medical devices essential principles 13.4 (15), (16). The Olympic Brainz Monitors are compliant to these electrical safety requirements per IEC 62353; however, they were not documented in the Olympic Brainz Monitor (OBM) Reference Manual EN (027050 Rev 06).
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are being provided with a Safety Addendum that includes instructions to conduct an electrical safety test of the device.
Contact Information	1800 737 222 - Paragon Care