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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 020 11 12 000
Date submitted: 11/6/2012
Manufacturer:Philips Healthcare
Device Type:DigitalDiagnost X-ray System
Description:DigitalDiagnost X-ray System
Medical Device Identifier:All DigitalDiagnost systems with Eleva software version 3.0.x
Reason of Field Safety Corrective Action:Philips previously notified owners of DigitalDiagnost systems with software releases 3.0.1 and 3.0.2, that a new software release, 3.0.3, would be installed on their systems. However, software release 3.0.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side if an image is rotated.
Remedy Action:Software release 3.0.4 corrects this defect in release 3.0.3, and it will be installed on affected systems in place of release 3.0.3. If software release 3.0.3 has already been installed on a system, it will be replaced with release 3.0.4.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:EEACB620412B1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare (2).pdf