FDA Device recall Z-1502-2014
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors by Varian Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1502-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-20 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080…Model H08: Code numbers: H080002 H080065 H080126 H080187 H080251 H080314 H080378 H080441 H080503 H080607 H080672 H080749 H080944 H080003 H080066 H080127 H080188 H080252 H080315 H080379 H080442 H080504 H080608 H080673 H080753 H080947 H080004 H080068 H080128 H080189 H080254 H080316 H080380 H080443 H080506 H080609 H080674 H080754 H080948 HOSOOOS H080069 H080129 H080190 H0802SS H080317 H080381 H080444 H080507 H080610 H080675 H0807SS H080950 H080006 H080071 H080130 H080191 H080256 H080318 H080382 H080445 H080508 H080611 H080676 H080756 H080960 H080008 H080072 H080131 H080192 H080257 H080319 H080383 H080446 H080509 H080612 H080677 H080759 H080961 H080009 H080073 H080132 H080193 H080258 H080320 H080384 H080447 HOSOSlO H080613 H080678 H080760 H080962 H080010 H080074 H080133 H080194 H080259 H080321 H08038S H080448 H080511 H080614 H080679 H080761 H080969 H080011 H080075 H080134 H080195 H080260 H080322 H080386 H080449 HOSOS12 H080615 H080680 H080762 H080970 H080012 H080076 H080136 H080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1502-2014%22
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