Z-2230-2019Class II

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Name: Z-2230-2019 iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Creator: Elekta, Inc.
Published: 2019-06-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2019-06-19 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2 on 2019-06-19. FDA classified it as Class II and gives the reason as "Potential for iGUIDE to incorrectly monitor the 3D position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2230-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-19
Posted: 2019-08-09
Terminated: 2024-05-06
Recalling firm: Elekta Limited
Product: iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential for iGUIDE to incorrectly monitor the 3D position.
Root cause tag: software
FDA root cause: Software Design Change
Action: Elekta, Inc. notified customers on about 06/19/2019 via URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were instructed to follow the below steps: 1. Log on to iGUIDE and move the 3D position. If the 3D position is equal to the PARK position, the system is not affected. 2. If the 3D position is not equal to the PARK position, log on to iGUIDE with Operator and Administrator rights. (If no user is available, go to the iGUIDE User Manager and add an appropriate user.). 3. Move the HexaPOD to the 3D Position (If 3D position is equal to the DRIVE position, both checkmarks will appear). 4. Open the HexaPOD properties (Left click the HexaPOD symbol on the system overview), which will display the HexaPOD properties. 5. Enter a rotation of 1.00 degree for any of the axis (RX, RY, RZ) and click Go to position. 6. Execute the pending movement. If the checkmark for the 3D position disappears and the EXTERNAL INHIBIT is set, your system is not affected by the comma / dot issue. No further actions are necessary. If the 3D position monitoring does not consider the 1.00 degree and the checkmark for the 3D position is still displayed and the EXTERNAL INHIBIT is not set, your system is affected! If the customer wants to still use a 3D workflow without imaging, do not rely on the 3D position indicator in iGUIDE. The HexaPOD should be moved to the PARK position first, then the 3D workflow can be started moving the HexaPOD back to the 3d position. Customers were also instructed to place the recall notice in a place accessible to all users (e.g. Instructions for Use, until this action is closed) and to advise the appropriate personnel, working with this product, on the content of this letter. A technical solution (iGUIDE patch) will be provided to correct the behavior. Until the iGUIDE patch is available, an interim solution can be implemented (change comma to dot) if your system is affected. Please consult your local Elekta represent
Quantity in commerce: 374 devices
Distribution: Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria, Belgium, Botswana, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Product codes and lots: Version 2.2.0, Product Code/GTIN Number: 04056719001704; Version 2.2.1, Product Code/GTIN Number: 04056719001742; Version 2.2.2, Product Code/GTIN Number: 04056719002039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2230-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2230-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09

Product code IYE

K072079Class IIIguide SystemMedical Intelligence Medizintechnik-GmbH-An Elekta / cleared 2007-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)