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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 094 07 17 000
Date submitted: 7/24/2017
Manufacturer:BrainLAB
Device Type:Airo Mobile CT scanner
Description:CT scanner
Medical Device Identifier:model# MobiCT-32, All Airo systems
Reason of Field Safety Corrective Action:Due to an issue with the configuration settings of the main-drive motion controller, if a main-drive motor has a broken encoder or sensor wire there is a risk of unintended motion while driving or transporting the AIRO system.
Remedy Action:Due to the risk of unintended motion and the potential unpredictable system behavior while driving / transporting the system, system operators are being asked to perform the following while preparing to drive / transporting the AIRO:

1. Ensure all obstacles, equipment, and/or bystanders are not closer than 1 meter from the front, back, and sides of the AIRO system when starting to drive / transport the system.

2. Do not stand directly behind the system when starting or initiating system movement.

a. Keep the Pendant in the Pendant Holster b. Hold onto the Pendant with both hands c. Stand to the left of center of the system when hitting the “Forward” or “Reverse” buttons to start driving the systems (see figure 1) d. Be aware that the system could move in a direction that was not expected.

3. Once system is in motion and reacting as expected, the operator may resume normal driving position, directly behind the system.

4. If the AIRO does not respond or incorrectly responds to motion commands, turn off the system and contact Brainlab Service as soon as possible.

Please provide a copy of this Field Safety Notification to all AIRO operators that drive or transport the AIRO system.

A new “WARNING” label (see figure 2) has been created and will need to be placed onto the AIRO system just above the pendant (see figure 3).
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:DC528E20AD289
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BrainLAB.pdf