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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 001 10 18 000
Date submitted: 10/2/2018
Manufacturer:Philips Healthcare
Device Type:DigitalDiagnost 4.1.9 / 4.2.6
Description:Ultrasound
Medical Device Identifier:-Stitching run on SkyPlate detector interrupted intermittently: Affects all DigitalDiagnost Systems with system software versions 4.1.x or 4.2.x and stitching license

-Stitching with SkyPlate aborts after first Image: Affects all DigitalDiagnost with system software versions 4.1.x or 4.2.x and stitching license

- System software CD contains wrong baseline: Affects All DigitalDiagnost systems with system software versions 4.1.8 and 4.2.5
Reason of Field Safety Corrective Action:-Stitching run on SkyPlate detector interrupted intermittently

-Stitching with SkyPlate aborts after first Image

-System software CD contains wrong baseline
Remedy Action:-Philips plans to install a system software version upgrade in affected systems, which will eliminate this issue.

-A Philips Service Engineer will contact you when the Field Action Kit is available to be implemented.

- Should you need to communicate with Philips with regard to this program, please reference Field Change Order 71200177.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:B9195615AF1EC
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf