X
Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
N
ational
C
enter for
M
edical
D
evices
R
eporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home
Published FSNs/Recalls
About NCMDR
Contact Us
FAQ
Login
NCMDR Recall
Back
Reference Number:
mdprc 031 04 11 000
Date submitted:
4/10/2011
Manufacturer:
Varian Medical Systems
Device Type:
Clinac Linear accelerator
Description:
Accelerator System, Linear
Medical Device Identifier:
Type 3 hard wedge assembies (Clinac Accessory) – see attached list of possibly affected units
Reason of Field Safety Corrective Action:
The wedge angle labeling on the wedge tray may not correctly match the wedge body. In all cases the wedge body is labeled with the correct wedge angle.
Remedy Action:
Immediately inspect all wedges to verify that the wedge angle label on the wedge body matches the wedge angle label on the wedge tray.
Athorized Representative/Importer/Distributor:
Varian Medical Systems, Riyadh (01) 2772126
Report Source:
NCMDR
Source Ref. Number:
BCCD790C75283
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments:
Manufacturer letter.pdf
View History
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.