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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 055 04 13 000
Date submitted: 4/21/2013
Manufacturer:BrainLAB
Device Type:Radiosurgery ,iPlan RT Dose system
Description:iPlan® RT is positioned to provide the best tools for both cranial and extracranial radiosurgery, meeting the highest accuracy tolerance required for safe, effective, and automated SRS and SBRT
Medical Device Identifier:iPlan RT Dose version 4.0 and 4.1 (including all subversions)
Reason of Field Safety Corrective Action:Potential incorrect dose calculation after modification of MLC shapes ( more details in attachment )
Remedy Action:User Corrective Action: Users of the iPlan RT Dose version 4.0 or 4.1 (including all subversions) shall adhere to one of the following actions: Automatic jaw position definition to avoid the occurrence of error, the jaws should be preferably configured as described below. Treatment plan for Brainlab m3 micro-MLC or Varian MLCs: • Make sure that “Automatically adapted to MLC” is selected in the Jaw Defaults in Beam Profile Editor 7.0/7.1 and • Only use automatic jaw adaption within iPlan RT Dose 4.0 and 4.1 during individual treatment planning. Treatment plan for Elekta BEAM Modulator: • Make sure that “Automatically adapted to MLC” is selected in the Jaw Defaults in Beam Profile Editor 7.0/7.1 There are no further actions to consider for individual treatment planning. Brainlab Corrective Action: 1. Existing potentially affected iPlan RT Dose version 4.0 or 4.1 customers receive this product notification information. 2. Brainlab will provide a software update with this issue solved to affected customers. Tentative planned timeline for availability: Dec 2013.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:4954743214157
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: BrainLAB.pdf