| 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 |
|
| 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.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9857 9179 - Customer Service Centre |