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 |
|
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 |