Reported Dec 13, 2023 · Ongoing
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, 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 Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- Lot codes and dates
- UDI/DI 05060191071529
- Serial Numbers
89 of 89 codes
153396153671109003153383153384153055153980154001154002154003154004154272153104153188153243153745153836153872153876154123154148154199154250154260154267154269154449154498154550152951153140153525153526153532154218153621153951153949154028154548154239154262153413153829154163154101152777153037153142153144153177153186153187153189153277153364153399153425153426153471
- Serial Numbers
363 of 363 codes
153722109005109007153003153008153314153337153427153428153482153649153900154023154024154050154087154299154300153248153699154043154395154435154179154131153658153830154221154473153976153128153608154505154531154325153406153601153607153667153720153723153751153839153862153940153985154055154076154140154149154283154293154296154375154421154398152843152912153778153893
- Amount recalled
- 451 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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