Z-1705-2016Class II

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment

Name: Z-1705-2016 iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment
Creator: Elekta, Inc.
Published: 2016-05-12
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-05-12 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment on 2016-05-12. FDA classified it as Class II and gives the reason as "If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented...". 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-1705-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-12
Posted: 2016-05-23
Terminated: 2021-07-16
Recalling firm: Elekta Limited
Product: iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.
Quantity in commerce: 20
Distribution: IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
Product codes and lots: Software iGUIDE 2.1 and 2.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1705-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1705-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-23

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)