Reported Jun 17, 2020 · Terminated
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation…
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 Unity, UDI 05060191071321, Image-guided radiation
- therapy system - Product Usageis indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan
- Lot codes and dates
- Serial numbers 600001 - 600043
- Amount recalled
- 32 units
Where it was sold
Why it was recalled
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
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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