Recall Z-1502-2014 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
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.
| Date | Apr 24, 2014 (initiated Mar 20, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Equipment maintenance |
| 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 directe |
| Quantity | 2622 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042720 | ON-BOARD IMAGER DEVICE Varian Medical Systems, Oct 29, 2004 |