On-Board Imager — Class II medical device recall Z-1502-2014
Terminated recall by Varian Medical Systems, Inc., reported 2014-04-30. Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board
| Recall number | Z-1502-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Palo Alto, CA, United States |
| Recall initiated | 2014-03-20 |
| Classified | 2014-04-24 |
| Reported by FDA | 2014-04-30 |
| Terminated | 2015-05-01 |
| Quantity | 2,622 |
| Model numbers | H08, H080002, H080003, H080004, H080065, H080066, H080068, H080126, H080127, H080128, H080187, H080188, H080189, H080251, H080252, H080254, H080314, H080315, H080316, H080378, H080379, H080380, H080441, H080442, H080443 and 15 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1502-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.