| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01243-1 |
| Product Name/Description |
O-arm O2 Surgical Imaging System
ARTG Number: 135566 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has determined that during servicing of certain internal components of the O-arm O2, it is possible that the high-power cable connector may come in contact with surrounding metal (toggle switch or the corner of battery tray) during the disconnecting/reconnecting process. If this occurs, it may result in an electrical short and a shock to the field service technician. Medtronic became aware of this issue via a complaint reported by a Medtronic field service technician. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is advising users that they are developing a retrofit service kit which will be installed during the next service visit for each O-arm O2 system, no later than 15 months from service kit availability. Users may continue to use the system prior to installation of the service kit.
This action has been closed out on 15/04/2021 |
| Contact Information |
02 9857 9179 - Medtronic |