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.
FDA Recall Z-1502-2014 · Posted 2014-04-24
Advertisement
Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-03-20
Date Terminated2015-05-01
Product Quantity2622
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.
Firm Action
Varian sent an Urgent Medical Device Correction letters March 20, 2014 to affected custoers via trackable mail. The letter was also distributed to Varian Sales, Marketing and Service organizations to inform them of the issues. The letter identified the affected product, description of problem, details, and recommended user actions to be taken. A Varian Customer Support Service representative will arrange a site visit to check the bel tension of the Type 01 elbow motors. If over tensioned belts are detected, the elbow motor will be replace with a Type O2 elbow motor. Questions may be directed to 888-827-4265.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement