| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00966-1 |
| Product Name/Description |
Medtronic O-Arm O2 Surgical Imaging System (a portable, diagnostic, fluoroscopic x-ray system)
Model Numbers: B1-700-00027, BI-700-00028
ARTG Number: 135566 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
After investigation of complaints, Medtronic has determined that the O-arm O2 system requires updates.
1. Certain aspects of the technical information in the Instructions for Use document require clarification. The information to be updated includes the system’s specification for x-ray filtration strength, leakage technique factors, tube housing cooling curves, technique factor measuring criteria, and air kerma reference location.
2. Radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply with requirements.
3. The x-ray technique factor display accuracy related to mA might not be compliant to the system specifications.
Please note that items 1 and 2 do not affect the safety or performance of the system. Item 3 does not increase the safety risk of the product to users or patients, but could affect performance related to image quality. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is providing users with updated errata sheets with updated the correct information and following this up with an update to the system software that corrects this information in the on-system Instructions for Use. In addition, Medtronic will be performing the appropriate measurements of air kerma rate, as well as testing the x-ray technique factor display accuracy for compliance.
This action has been closed-out on 22/03/2018. |
| Contact Information |
02 9857 9170 - Medtronic |