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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 04 12 000
Date submitted: 4/3/2012
Manufacturer:Philips Healthcare
Device Type:Radiographic/Fluoroscopic Systems
Description:Radiographic/Fluoroscopic Systems, Angiography/Interventional
Medical Device Identifier:System: Allura Systems FD10 , FD20, FD10/10, FD20/10 and FD20/20 (*) shipped between November 15th 2011 and March 15th 2012 that include an Actuator with an assembly error (Actuator Short Assy: 989600-184-665 and Actuator Long Assy: 989600-184-654). A limited number of Allura Sytems (3 FD10 and 1 FD20/20) (**) in which the Actuator has been replaced by an Actuator with an assembly error. (*) Productcodes: 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025 (**) Product codes: 722001, 722003 and 722008
Reason of Field Safety Corrective Action:Philips Healthcare has received reports of three occurrences where the Monitor Ceiling suspension system fell to its lowest position. In one occasion it collided with the table top. No patient harm has been reported. The investigation initiated concluded that the cause of the failure was an assembly error of the Actuator of the MCS.
Remedy Action:In order to avoid any risk for patients, users or bystanders we recommend the following until the containment action has been implemented. When system in use, we recommend that you: - do not position or move the Monitor Ceiling Suspension above the patient. - do not allow staff to stand under or close to the Monitor Ceiling Suspension. In addition, please avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCMDR
Source Ref. Number:37B8EA5528256
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments