Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only
Medical device recall Z-0065-2019. Published in FDA’s Enforcement Report on Oct 10, 2018.
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 Oct 10, 2018. 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
- 690 systens 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?
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
690 systens, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Software: Kingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial, MR1, MR2, MR3) V5.0.1749 Serial numbers: 248-010 248-013 248-016 248-021 248-022 248-030 248-038 248-041 248-042 248-048 248-054 248-063 248-064 248-069 248-070 248-071…
Every code shown here, 1,997 characters
Software: Kingsbury V5.0.1747 Wembley Park V5.0.1748 Neasden (Initial, MR1, MR2, MR3) V5.0.1749 Serial numbers: 248-010 248-013 248-016 248-021 248-022 248-030 248-038 248-041 248-042 248-048 248-054 248-063 248-064 248-069 248-070 248-071 248-072 248-076 248-080 248-083 248-084 248-085 248-087 249-0003 249-0004 249-0005 249-0006 249-0008 249-0009 249-0010 249-0011 249-0012 249-0013 249-0014 249-0015 249-0016 249-0017 249-0018 249-0019 249-0020 249-0021 249-0022 249-0023 249-0024 249-0025 249-0026 249-0027 249-0028 249-0029 249-0030 249-0031 249-0032 249-0033 249-0034 249-0035 249-0036 249-0037 249-0043 249-0045 249-0047 249-0055 249-0056 249-0057 249-0058 249-0061 249-0069 249-0071 249-0072 249-0073 249-0074 249-0075 249-0076 249-0077 249-0078 249-0079 249-0080 249-0081 249-0082 249-0083 249-0084 249-0085 249-0086 249-0087 249-0088 249-0089 249-0090 249-0091 249-0095 249-0096 249-0097 249-0098 249-0099 249-0100 249-0101 249-0102 249-0103 249-0107 249-0108 249-0109 249-0110 249-0111 249-0113 249-0114 249-0115 249-0116 249-0117 249-0118 249-0125 249-0126 249-0127 249-0128 249-0129 249-0130 249-0131 249-0133 249-0137 249-0141 249-0142 249-0147 249-0152 249-0155 249-0162 249-0163 249-0164 249-0169 249-0170 249-0171 249-0172 249-0173 249-0174 249-0175 249-0176 249-0177 249-0178 249-0179 249-0180 249-0181 249-0182 249-0183 249-0184 249-0185 249-0186 249-0187 249-0188 249-0189 249-0190 249-0191 249-0195 249-0196 249-0205 249-0206 249-0224 249-0226 249-0227 249-0239 249-0240 249-0243 249-0244 249-0251 249-0253 249-0254 249-0256 249-0272 249-0273 249-0274 249-0275 249-0276 249-0286 249-0288 249-0289 249-0290 249-0293 249-0304 249-0305 249-0306 249-0307 249-0308 249-0309 249-0310 249-0311 249-0312 249-0313 249-0314 249-0315 249-0316 249-0317 249-0318 249-0319 249-0320 249-0321 249-0322 249-0323 249-0324 249-0329 249-0330 249-0331 249-0332 249-0333 249-0334 249-0335 249-0336 249-0337 249-0338 249-0339 249-0340 249-0341 249-0342 249-0347 249-0348 249-0349 249-0350 249-0351…
FDA’s list runs to 6,443 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.
Nationwide Foreign: Australia, Austria, Azerbaijan, Belgium, Brunei, Bulgaria, Canada, China, Croatia, Denmark, Finland, Georgia, Germany, India, Israel, Italy, Japan, Korea, Lithuania, Malaysia, Morocco, Norway, Poland, Portugal, Puerto Rico, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
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 Aug 24, 2018.
- FDA classified it on Oct 3, 2018.
- FDA’s Enforcement Report published it on Oct 10, 2018.
- FDA terminated it on Jul 8, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Vision RT Ltd, of London, United Kingdom.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 6,443 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.