Z-3017-2017Class II

iGUIDE Software 2.2

Name: Z-3017-2017 iGUIDE Software 2.2
Creator: Elekta, Inc.
Published: 2017-06-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-06-19 / Terminated

FDA source

Elekta, Inc. began a recall of iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment on 2017-06-19. FDA classified it as Class II and gives the reason as "Incorrect PEC values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3017-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-19
Posted: 2017-08-10
Terminated: 2019-11-05
Recalling firm: Elekta Limited
Product: iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Incorrect PEC values.
FDA root cause: Unknown/Undetermined by firm
Action: Elekta sent an Urgent Important Field Safety Notice 618-01-303-026 letter dated June 2017 to all affected customers. The letter identified the affected product, problem, the potential clinical impact and actions to be taken.. It also provides a workaround to avoid the issue.
Quantity in commerce: 110 units
Distribution: Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, & Vietnam.
Product codes and lots: Scope; iGUIDE 2.2.0, iGUIDE 2.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3017-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3017-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-16	2017-08-10

Product code IYE

K143485Class IIiGuide 2.1Medical Intelligence Medizintechnik GmbH / cleared 2015-03-04

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)