Reported Dec 13, 2023 · Ongoing
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator,…
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, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Lot codes and dates
- UDI/DI 05060191071505
- Serial Numbers
256 of 256 codes
154549151917151963152072152081152131152382151838152318152807151951152416153147153148153963151821151845151940152160152162152164152389152393152394152634152635152636152664152665152725152992151850151920152082152089152111152546152548152299152403152503152676152950151857151690151744151745151766151831151859151900151950152046152137152194152202152216152258152276152376
- UDI/DI05060191071550
- Serial Numbers
763 of 763 codes
152008153854153863153954153995109002152007152369152379152619152695152696152896152897152905152926153007153012153014153024153152153276153033153220151836153449154138151868152188152533152093152363152472154042152005152056152259152272152354152500152689152796153022153943154263154384153728151928152124152166152242152244152651151673153038151403151624151663151948151970
- Amount recalled
- 1019 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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