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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 064 06 18 000
Date submitted: 6/17/2018
Manufacturer:Philips Healthcare
Device Type:Allura Xper, UNIQ and Centron
Description:Interventional X-ray system
Medical Device Identifier:Allura 8.1.25, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25, Allura 8.2.25.5, Allura 8.2.27, UNIQ 1.0.10, UNIQ 1.0.10.5, Centron 1.0.10, Centron 1.0.10.1, Centron 1.0.10.5.
Reason of Field Safety Corrective Action:The first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Remedy Action:Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.

Customer shall ensure that all staff with access to the affected systems are informed of the contents of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips.

The problem will be resolved by a software update, which is expected to be available by the second half of 2018.

You will be notified by your local Philips representative when the software update is available for installation.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:2D36353158121
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf