Recall Z-1502-2014— Varian Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2014-03-20, terminated 2015-05-01. It names one FDA 510(k) clearance: K042720. Product: 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.. Reason: 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..
- Recalling firm
- Varian Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-20
- Terminated
- 2015-05-01
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.