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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00965-1
Product Name/Description O-Arm 1000 Surgical Imaging System (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 1000 system requires updates.

1.Technical information in the IFU require clarification, including specifications for x-ray technique factor accuracy, filtration strength, leakage technique factors, air kerma reference location, and tube housing cooling curves.

2. Radiation measurement methodologies associated with confirming the accuracy specifications of the air kerma displays do not fully comply.

3. The x-ray technique factor display accuracy related to mA and mAs do not comply.

4. X-ray generator and motion batteries require inspection to insure they are not damaged.

Items 1 & 2 do not affect the safety or performance of the system. Item 3 could affect performance related to image quality. Item 4 addresses possible shipping damage to the batteries. Damaged batteries may result in odours/fumes, smoke, and the system not functioning as intended.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is providing users with updated errata sheets with 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. A visual and electrical inspection of the batteries will also be undertaken for any potential damage.
This action has been closed-out on 22/03/2018.
Contact Information 02 9857 9170 - Medtronic Australasia