IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator
Medical device recall Z-2082-2019. Published in FDA’s Enforcement Report on Jul 31, 2019.
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 31, 2019. 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
- 496 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?
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
496 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742 iGuide 2.2.2 = 04056719002039 Installed on the following units: Master Devices with serial numbers: VERSA HD/30002624-003/154166 VERSA HD/30000782-003/153788 VERSA…
Every code shown here, 1,996 characters
UDI (GTIN) iGuide 2.2.0 = 04056719001704 iGuide 2.2.1 = 04056719001742 iGuide 2.2.2 = 04056719002039 Installed on the following units: Master Devices with serial numbers: VERSA HD/30002624-003/154166 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 VERSA HD/30000782-003/153788 ELEKTA INFINITY/19175-003/154363 VERSA HD/30001056-002/109016 VERSA HD/30001009-001/153427 ELEKTA INFINITY/11766-003/152570 VERSA HD/11766-004/153649 ELEKTA SYNERGY/11766-002/151717 VERSA HD/17114-001/153383 VERSA HD/19677-005/109018 VERSA HD/30003910-LIN001/109005 VERSA HD/30003903-LIN001/109006 VERSA HD/30003903-LIN002/109035 VERSA HD/30001230-003/153428 VERSA HD/15081-LIN003/109003 ELEKTA SYNERGY/15081-002/152131 VERSA HD/12486-003/109036 VERSA HD/15240-003/109033 ELEKTA SYNERGY/15240-001/152128 ELEKTA SYNERGY/15240-002/152419 ELEKTA SYNERGY/20967-001/153012 VERSA HD/30003249-001/154299 VERSA HD/14756-002/153003 ELEKTA SYNERGY/14756-001/151916 ELEKTA SYNERGY/12579-003/152379 ELEKTA AXESSE/18225-001/152691 VERSA HD/18225-003/153900 VERSA HD/30001349-001/154087 VERSA HD/20965-001/153008 VERSA HD/30002428-LIN001/154024 ELEKTA AXESSE/11654-003/152617 VERSA HD/11654-006/109013 VERSA HD/10394-AKHEE/153248 VERSA HD/12570-#001/154395 VERSA HD/12570-#002/154435 VERSA HD/12490-KLG02E/154043 VERSA HD/12490-KLG04/153699 VERSA HD/17152-#001/156066 ELEKTA SYNERGY/10266-IBK02E/152807 VERSA HD/10266-IBK05/153055 VERSA HD/10266-IBK01E/154680 ELEKTA SYNERGY/10266-IBK04/151431 VERSA HD/11517-C8230/154221 VERSA HD/11517-C8220/154473 ELEKTA SYNERGY/11517-C8210/151888 ELEKTA SYNERGY/11517-C8200/151483 VERSA HD/10587-001/154730 VERSA HD/16805-002/153976 VERSA HD/30003118-002/154744 VERSA HD/30003118-001/154743 VERSA HD/30003118-003/154745 VERSA HD/30003118-004/154746 ELEKTA INFINITY/14770-003/153005 iGUIDE Software/14770-001/2.2.2 ELEKTA INFINITY/12473-012/152957 ELEKTA INFINITY/12473-013/152956 ELEKTA INFINITY/15012-008/152853 ELEKTA INFINITY/15012-007/153015 ELEKTA INFINITY/13219-004/153852 ELEKTA…
FDA’s list runs to 15,259 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 - US Nationwide
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 Jul 18, 2019.
- FDA classified it on Jul 25, 2019.
- FDA’s Enforcement Report published it on Jul 31, 2019.
- FDA terminated it on Aug 11, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medical Intelligence Medizintechnik Gmbh, of Schwabmunchen, Germany.
- 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 15,259 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.