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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 034 04 13 000
Varian Medical Systems
Patient monitoring system, respiratory, radiation procedure, RPM Respiratory Gating System
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.
(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.
Varian Medical Systems, Riyadh, (01) 2772126
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Varian Medical Systems.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.