On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ’’Type 01” elbow motors
Medical device recall Z-1502-2014. Published in FDA’s Enforcement Report on Apr 30, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 30, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 2622 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
2622, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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 H080196 H080261 H080324 H080387 H080450 H080513 H080616 H080683 H080763 H080971 H080013 H080077 H080137 H080197 H080262 H080325 H080389 H080451 H080514 H080617 H080684 H080764 H080989 H080014 H080078 H080138 H080198 H080263 H080326 H080391 H080452 H08051S H080618 H080685 H080766 H080991 H080016 H080079 H080139 H080199 H080264 H080327 H080392 H080453 H080516 H080619 H080686 H080768 H080997 H080017 HOSOOSO H080141 H080200 H080266 H080328 H080393 H080454 H080517 H080620 H080687 H080772 H081001 H080018 HOSOOSl H080142 H080202 H080267 H080329 H080394 H080455 H080518 H080621 H080688 H080773 H081004 H080019 H080082 H080143 H080203 H080268 H080330 H080395 H080456 H080519 H080622 H080689 H080774 H081005 H080020 H080083 H080144 H080204 H080269 H080331 H080396 H080457 H080520 H080623 H080690 H080775 H081006 H080021 H080084 H080145 H080205 H080270 H080332 H080397 H080458 H080521 H080624 H080691 H080778 H081007 H080022 H080085 H080147 H080206 H080271 H080333 H080398 H080459 H080522 H080625 H080692 H080783…
FDA’s list runs to 21,001 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution.
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 20, 2014.
- FDA classified it on Apr 24, 2014.
- FDA’s Enforcement Report published it on Apr 30, 2014.
- FDA terminated it on May 1, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Varian Medical Systems, Inc., of Palo Alto, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,001 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.