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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 034 04 13 000
Date submitted: 4/9/2013
Manufacturer:Varian Medical Systems
Device Type:Patient monitoring system, respiratory, radiation procedure, RPM Respiratory Gating System
Description:Patient monitoring system, respiratory, radiation procedure
Medical Device Identifier:RPM Gating v1.7.5 with 3D Option; LIST OF SERIAL NUMBERS (see attached)
Reason of Field Safety Corrective Action:While operating with the 6-dot marker block, above version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
Remedy Action:(1) Please refer to the RPM Respiratory Gating System Reference Guide for recommended placement of the marker block on the patient. (2) Instructions for detecting and preventing inverted trace: (See Attached). Varian Medical Systems has developed a technical correction for this issue. You will be contacted by a Customer Service representative to schedule its installation on your system.
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh, (01) 2772126
Report Source:NCMDR
Source Ref. Number:0E80FA5C171FB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Varian Medical Systems.pdf