Reported Dec 13, 2023 · Ongoing
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy…
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?
- ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Lot codes and dates
- UDI/DI 05060191071512
- Serial Numbers
119 of 119 codes
153451154067154072153600153693152596152649152834152956152957153005153054153377153593153602153617153852154048154049154060152971152597151995153685154560153748153979153989152902153670152937153198151839151942151958151959151961152019152103152115152158152207152210152211152223152257152303152364152371152504152520152585152593152604152652152659152715152732152801152802
- Serial Numbers
173 of 173 codes
153741154363152506152768152969153004153047153048153120153121152478152772153303153402153626152668152669152692152853152979152984153015153017153053153308153802154065153946153960154082154130154144154189154229154289154290154302154311154414154423154475153472152888153298154277154297154310154355154434151044152554153076153237153324153586153961154211154403154231153441
- Amount recalled
- 291 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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.