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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 089 04 16 000
Date submitted: 4/24/2016
Manufacturer:Philips Healthcare
Device Type:MobileDiagnost wDR 2
Description:X-ray
Medical Device Identifier:All MobileDiagnost wDR 2
Reason of Field Safety Corrective Action:1. The system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “Normal”), even though the patient type “Newborn” was selected and is displayed in the generator control area of the Eleva User Interface.

2. Under certain condition, the detector might not be ready for examination. Released x-ray might lead to an image with artifacts and a retake is required.

While the attachment process is running, the detector might be too short in front of the IR (Infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
Remedy Action:1. Check the exam parameter before exposure and change them if necessary manually.

2. Avoid this by holding the detector while the attachment is running in front of the IR (infrared) sensor until the LEDs on the detector are solid green and do not blink anymore. The second possibility why this can happen is that before an exposure the already attached detector is in sleep mode. The customer should take care that before an exposure all LEDs are also solid green at any time.

When following the safety notices the system can be used according to the Instruction for Use without restrictions. If the customer feels uncertain, they can contact Philips.

Philips is preparing a Field Action Kit, which will allow a Philips Service Engineer to update the software to version 2.0.4.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:2F329B86B923B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf