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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 080 01 11 000
Date submitted: 1/30/2011
Manufacturer:Philips Healthcare
Device Type:Fixing Strap of the Laser Aiming Device Image Intensifier, Mobile X-Ray
Description:Radiographic Units, Mobile
Medical Device Identifier:The fixing strap of the Laser aiming device II 9” / 12” (sales number: NMCA240, NMCA241, NMCA242, NMCA243). The device is an option delivered for Philips mobile X-ray units: 718022 BV Libra, Mobile X-ray unit 718040 FIELD EXTENSIONS for BV LIBRA 718074 BV Endura, rel. 2 718095 BV Pulsera, rel. 2.3 718120 FIELD EXTENSIONS for BV ENDURA and 718121 FIELD EXTENSIONS for BV PULSERA
Reason of Field Safety Corrective Action:The fixing strap of these laser aiming devices may inadvertently be detached and land on a patient.
Remedy Action:Philips urgently asks users of the affected device to fix the closed latch body of the draw latch to the metal band using a tie wrap. This will eliminate any immediate risk to the patient. Without such temporary measure, the device should not be used.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:E165A0A8E8376
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: XCR603-100421 FSN Field Safety Notification Surgery laser device FCO71800035 final.pdf