Elekta Unity Radiation Therapy System Recalled for Legionella Risk

Plain-English summary

Elekta, Inc. is recalling 32 units of the Elekta Unity image-guided radiation therapy system (UDI 05060191071321). The recall affects serial numbers 600001 through 600043. These systems are indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body.

The recall is issued because of a potential risk that Legionella may be present in the Unity machine room, specifically in the heat exchanger condensation collection tray. The agency has classified this recall as Class II.

The affected units were distributed worldwide, including in the United States (PA, WI, NY, TN, NJ, IA, TX) and in Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, and the UK. Healthcare facilities and users should contact Elekta, Inc. for instructions on how to address the potential Legionella risk.

The recalled product

Product

Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is 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 a

Manufacturer

Elekta, Inc.

Category

Medical Device — Radiation Therapy

Hazard

• legionella

Affected units

32

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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