Reported Dec 13, 2023 · Ongoing
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System…
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 Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Lot codes and dates
- UDI/DI 05060191071536
- Serial Numbers
152110153550153363152650151851153300152721152816152539153879154099154121154230154581151909152186152314152542152728152643151984153334152057152086152107152129152907153327153820153844153084151712151713153522151873152501153675151834151923151924151925152076154100151725151804151825151826152337152338152339152662152936153629153632153676153678152397153636UDI/DI 05060191071567
- Serial Numbers
206 of 206 codes
152718153868153870153877153948154180152778151562151563151991151992151993152213152450152456152531152642152663152782152791152829152862152962153125153270153343153759153789153886154145154147154247154330154499153925154201152171152280151750152221152255152509152558152612152831153066153135153229153246153704153772154191154428154510152146152355151994152001153098152436
- Amount recalled
- 264 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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