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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 156 06 12 000
Date submitted: 6/27/2012
Manufacturer:Philips Healthcare
Device Type: Information Systems, Xcelera Connect R2.1L1 SP2
Description: Information Systems, Data Management, Cardiology
Medical Device Identifier: Xcelera Connect R2.1L1 SP2
Reason of Field Safety Corrective Action: Incomplete information arriving from unformatted reports interface
Remedy Action: Affected systems will be updated to SP4. A Philips representative will contact you to schedule the implementation of this update when it becomes available. The update will be provided at no charge.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01)2119948
Report Source:NCMDR
Source Ref. Number: E8334AA5B62C0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare (1).pdf