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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00093-1
Product Name/Description O-Arm 1000 Imaging System (3rd Edition)

ARTG Number: 168216
(Medtronic Australasia - X-ray system, diagnostic, fluoroscopic, general-purpose, application program software)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/01/2018
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue In July 2017, Medtronic Navigation rolled out routine SW Update 3.2.1. This update is in response to customer complaints and addresses several known software anomalies. The software anomalies were reported to affect system behaviour that include the following issues:

• Inability to power the system after shutdown
• System stays in standalone mode
• Image reconstruction
• System/Pendant bootup
• Dose display/report
• Gantry motion
• Network communication
• System shutdown
• Early termination of 3D spin

In 3 instances, these software anomalies have resulted in aborting use of the O-arm and reschedule of surgeries after incision.
Recall Action Product Defect Correction
Recall Action Instructions Medtronic will be in contact with customers to arrange for the software update to be installed.
Contact Information 02 9857 9179 - Customer Service Centre