Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian’s TrueBeam EDGE
Medical device recall Z-2149-2016. Published in FDA’s Enforcement Report on Jul 20, 2016.
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 Jul 20, 2016. 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
- 166 OSMS in US, 23 OSMO - International, 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 Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian’s TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
166 OSMS in US, 23 OSMO - International,, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
TrueBeam version 2.0/2.5 with any version OSMS. OSMA serial numbers: HOM0084 HOM0176 HOM0368 HOM0003 HOM0004 HOM0005 HOM0006 HOM0008 HOM0009 HOM0010 HOM0011 HOM0012 HOM0015 HOM0016 HOM0017 HOM0018 HOM0019 HOM0020 HOM0021 HOM0022 HOM0023…
Every code shown here, 1,709 characters
TrueBeam version 2.0/2.5 with any version OSMS. OSMA serial numbers: HOM0084 HOM0176 HOM0368 HOM0003 HOM0004 HOM0005 HOM0006 HOM0008 HOM0009 HOM0010 HOM0011 HOM0012 HOM0015 HOM0016 HOM0017 HOM0018 HOM0019 HOM0020 HOM0021 HOM0022 HOM0023 HOM0024 HOM0025 HOM0026 HOM0027 HOM0028 HOM0029 HOM0030 HOM0031 HOM0032 HOM0033 HOM0034 HOM0035 HOM0036 HOM0037 HOM0071 HOM0072 HOM0073 HOM0074 HOM0075 HOM0076 HOM0077 HOM0078 HOM0079 HOM0080 HOM0081 HOM0082 HOM0083 HOM0084 HOM0085 HOM0086 HOM0087 HOM0088 HOM0089 HOM0090 HOM0091 HOM0095 HOM0096 HOM0097 HOM0098 HOM0099 HOM0100 HOM0101 HOM0102 HOM0103 HOM0107 HOM0108 HOM0109 HOM0110 HOM0111 HOM0113 HOM0114 HOM0115 HOM0116 HOM0117 HOM0118 HOM0125 HOM0126 HOM0127 HOM0128 HOM0129 HOM0170 HOM0171 HOM0172 HOM0173 HOM0174 HOM0175 HOM0176 HOM0177 HOM0178 HOM0179 HOM0180 HOM0181 HOM0182 HOM0183 HOM0184 HOM0185 HOM0186 HOM0187 HOM0188 HOM0189 HOM0190 HOM0191 HOM0304 HOM0305 HOM0306 HOM0307 HOM0308 HOM0309 HOM0310 HOM0311 HOM0312 HOM0313 HOM0314 HOM0315 HOM0316 HOM0317 HOM0318 HOM0319 HOM0320 HOM0321 HOM0322 HOM0323 HOM0324 HOM0329 HOM0330 HOM0331 HOM0332 HOM0333 HOM0334 HOM0335 HOM0336 HOM0337 HOM0338 HOM0339 HOM0340 HOM0341 HOM0342 HOM0347 HOM0348 HOM0349 HOM0350 HOM0351 HOM0352 HOM0353 HOM0354 HOM0356 HOM0357 HOM0358 HOM0359 HOM0360 HOM0361 HOM0362 HOM0363 HOM0364 HOM0365 HOM0366 HOM0367 HOM0368 HOM0369 HOM0370 HOM0371 HOM0372 HOM0373 HOM0374 HOM0381 HOM0382 HOM0383 HOM0386 HOM0387 HOM0388 HOM0389 HOM0390 HOM0391 HOM0392 HOM0393 HOM0394 HOM0395 HOM0396 HOM0403 HOM0404 HOM0405 HOM0406 HOM0409 HOM0410 HOM0411 HOM0412 HOM0413 HOM0414 HOM0415 HOM0416 HOM0420 HOM0421 HOM0422 HOM0424 HOM0440 HOM0441 HOM0442 HOM0444 HOM0445 HOM0447 HOM0448 HOM0454 HOM0457 HOMWMZ1.
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: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, 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 Jun 23, 2016.
- FDA classified it on Jul 11, 2016.
- FDA’s Enforcement Report published it on Jul 20, 2016.
- FDA terminated it on Aug 24, 2018.
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.”
- 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
-
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.