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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 Medtronic Australasia Pty Ltd
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