FDA-Device2014-04-30Class II
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
Varian Medical Systems, Inc.
Hazard
Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
Sold states
Worldwide Distribution.
Affected count
2622
Manufactured in
911 Hansen Way, N/A, Palo Alto, CA, United States
Products
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1502-2014Don't want to check this manually?
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