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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 024 01 15 000
Date submitted: 1/5/2015
Manufacturer:Philips Healthcare
Device Type:Philip’s Anesthesia Machines
Description:Anesthesia Machines
Medical Device Identifier:The following products and S/N ranges may be affected:

Siesta i Breasy (P/N # 866204/10652-00): S/N: 200XXXXXX, AMXXXXXXX, DK30100002-DK301000032

Siesta i Whispa (P/N # 866202/10651-00): S/N: 200XXXXXX, AMXXXXXXX, DK30100001-DK301000151

Dameca MRI 508 (P/N # 866203/10651MRI-00): S/N: 200XXXXXX, AMXXXXXXX, DK30100001-DK301000082, MRI5087001-MRI5087218

Siesta i TS (P/N # 866163/10653-00): S/N: 200XXXXXX, AMXXXXXXX, DK25100001-DK25100031

IntelliSave AX700 (P/N # 866205/10623-00): S/N: AMXXXXXXX, DK30100001-DK40601022
Reason of Field Safety Corrective Action:The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function.
Remedy Action:The customer should read the Field Safety Notice and ensure that they understand it and that all personnel using the device are informed about the content in this Field Safety Notice.

An anesthesia machine that has a control dial that gets stuck can continue to be used as the control dial can be pulled out, making the control dial work. If a machine is exhibiting the issue with the control dial getting stuck, Philips should be contacted in order to have the control dial replaced. Customers with devices that exhibit control dial issue will receive a replacement control dial free of charge.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:DAE181785D311
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare 3.pdf