Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option
Medical device recall Z-1163-2013. Published in FDA’s Enforcement Report on May 1, 2013.
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 May 1, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2508 units 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 an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
2508 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618…
Every code shown here, 1,999 characters
CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 HS01090 HS01291 HS01489 HS01686 HS01888 HS02070 HS02262 HS02392 HS02565 HS00039 HS00410 HS00639 HS00829 HS01093 HS01296 HSOI490 HS01694 HS01889 HS02072 HS02263 HS02395 HS02566 HS00043 HS00420 HS00640 HS00843 HS01094 HS01299 HSOI498 HS01696 HS01890 HS02080 HS02267 HS02397 HS02567 h500044 HS00422 HS0064l HS008Sl HSOllOO HS01303 HS01499 HS01697 HS01893 HS02083 HS02268 HS02399 HS02569 HS00049 HS00433 HS00643 HS00856 HSOIIOS HS01307 HSOISOO HS01698 HS01895 HS02085 HS02269 HS02401 HS02573 HSOOOSO HS00434 HS00644 HS00873 HSOI106 HS01308 HSOIS03 HS01700 HS01896 HS02087 HS02278 HS02403 HS02574 HS00073 HS00435 HS00646 HS00879 HS01108 HS013ll HSOISIO HS01704 HS01897 HS02088 HS02279 HS02406 HS02575 HS00074 HS00440 HS00649 HS00881 HS01109 HS01313 HSOISll HS01707 HS01900 HS02090 HS02280 HS02408 HS02576 HS00075 HS00443 HS00654 HS00890 HSOI113 HS01314 HSOISIS HS01708 HS01902 HS02097 HS02282 HS02409 HS02584 HS00077 HS00452 HS00664 HS00892 HSOlll9 HS01320 HSOIS25 HS01709 HS01908 HS02099 HS02283 HS024ll HS02586 HS00078 HS004SS…
FDA’s list runs to 20,183 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 - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 26, 2013.
- FDA classified it on Apr 23, 2013.
- FDA’s Enforcement Report published it on May 1, 2013.
- FDA terminated it on Jul 9, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Varian Medical Systems, Inc. Oncology Systems, 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 20,183 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.