CLASS II Device recall · Reported 16 Aug 2017 · FDA Enforcement Report

iGUIDE Software 2.2 Product Usage: Control of accurate patient recalled

Elekta is recalling iGUIDE Software 2.2 Product Usage: Control of accurate patient, distributed in 21 states. The recall was initiated on 19 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesScope; iGUIDE 2.2.0, iGUIDE 2.2.1

Quantity recalled110 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3017-2017
FDA event ID: 77590
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 19 Jun 2017
FDA classified: 10 Aug 2017
Reported: 16 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

19 Jun 2017	Recall initiated by company
10 Aug 2017	Classified by FDA	+52 days
16 Aug 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect PEC values.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

Where it was distributed

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.

Alaska Connecticut Georgia Hawaii Kentucky Louisiana Massachusetts Maryland Minnesota North Carolina New Mexico Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Virginia

Questions about this recall

Is iGUIDE Software 2.2 Product Usage: Control of accurate patient recalled?

Yes. Elekta recalled iGUIDE Software 2.2 Product Usage: Control of accurate patient on 19 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3017-2017.

Why was it recalled?

Incorrect PEC values.

Which lots are affected?

Scope; iGUIDE 2.2.0, iGUIDE 2.2.1

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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