Reported Mar 12, 2014 · Terminated
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear…
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 · Atlanta, GA · 30346-1227
Is this the product you have?
- Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
- Lot codes and dates
- Model 3.1
- Amount recalled
- 134
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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.