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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 139 07 16 000
Date submitted: 7/24/2016
Manufacturer:Medtronic SA
Device Type:O-arm® 1000 and O-arm® O2 Surgical Imaging Systems
Description: Surgical Imaging device
Medical Device Identifier:1) O-arm® 1000 Surgical Imaging System:
- Model numbers BI-700-00027 and BI-700-00028
2) O-arm® O2 Surgical Imaging System:
- Model number BI-700-02000
Reason of Field Safety Corrective Action:1. Certain aspects of the technical information in the Instructions for Use document require clarification. The information to be updated includes system’s specification 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 with requirements.
3. The O-arm System X-ray technique factor display accuracy related to mA and mAs might not be compliant to the system specifications.
4. X-ray generator and motion batteries require inspection to insure they are free from damage during shipment.
Remedy Action:Medtronic is providing to customers an errata sheet with the correct information. Medtronic will be following up this errata sheet with an update to your system software that corrects this information in the on-system Instructions for Use. In addition, they will be performing the appropriate measurements of air kerma rate, as well as testing the X-ray technique factor display accuracy for compliance. They will also be visually and electrically inspecting the batteries for potential damage. Your local service representative will contact you to schedule the update when it becomes available.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:7DEE739B682E1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf