Reported Aug 21, 2019 · Terminated
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
- Lot codes and dates
- Version 2.2.0
- Product Code/GTIN Number
04056719001704Version 2.2.1
- Product Code/GTIN Number
04056719001742Version 2.2.2
- Product Code/GTIN Number04056719002039
- Amount recalled
- 374 devices
Where it was sold
Why it was recalled
Potential for iGUIDE to incorrectly monitor the 3D position.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Elekta, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.