Z-1807-2014Class II

iGUIDE System

Name: Z-1807-2014 iGUIDE System
Creator: Elekta, Inc.
Published: 2014-05-29
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-05-29 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a... on 2014-05-29. FDA classified it as Class II and gives the reason as "A bug in the software prevents the iGUIDE software from logging off". 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-1807-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-06-17
Terminated: 2017-09-29
Recalling firm: Elekta Limited
Product: iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A bug in the software prevents the iGUIDE software from logging off.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice 618 01 303 024 dated May 29, 2014 to affected customers. The letter identified the affected product, problem, potential clinical impact and actions to be taken. It also gives a recommendation how the risk can be mitigated - Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. The notice also advises the customer that a patch will be released that corrects the behavior of the iGUIDE software. This solution will be implemented on all affected products when available. For questions contact your local Elekta office.
Quantity in commerce: 224
Distribution: Worldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam
Product codes and lots: Software Versions 2.0.0, 2.0.1 and 2.0.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1807-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1807-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)