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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 098 12 13 000
Date submitted: 12/11/2013
Manufacturer:Philips Healthcare
Device Type:GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore, TruFlight Select, GEMINI TF Ready and GEMINI LXL PET/CT Systems
Description:PET Reconstruction Server (PRS) database
Medical Device Identifier:GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.1,

GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 35.1.1,

GEMINI TF PET/CT 16, GEMINI TF PET/CT 64, GEMINI TF Ready and GEMINI LXL Software Version 3,5.2,

GEMINI TF PET/CT 16 and GEMINI TF PET/CT 64 Software Version 3.5.2.1,

GEMINI TF Big Bore Software Version 3.6;,

GEMINI TF Big Bore Software Versions 3.6.1 and 3.6.2,

TruFlight Select systems Software Version V3.5.3

Reason of Field Safety Corrective Action:The PET Reconstruction Server (PRS) database may lock up after a CT acquisition is completed and before a PET acquisition is started on GEMINI TE 16, GEMINI TF 64, GEMINI TF Big Bore, TruFlight Select, GEMINI TF Ready and GEMINI LXL PET/CT Systems
Remedy Action:Philips healthcare field service engineer will contact you for implementation of the software update on your affected system(s).
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, (011) 2114547
Report Source:NCMDR
Source Ref. Number:BC31606F8F24B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips.pdf