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 accordance with a defined treatment plan.
Reported: June 17, 2020 Initiated: April 30, 2020 #Z-2289-2020
Product Description
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 accordance with a defined treatment plan.
Reason for Recall
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 32 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX, and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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 accordance with a defined treatment plan.. Recalled by Elekta, Inc.. Units affected: 32 units.
Why was this product recalled? ▼
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2289-2020.
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