Recall Z-2289-2020— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2020-04-30, terminated 2021-08-04. It names one FDA 510(k) clearance: K192482. 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 accordance with a defined treatment plan.. Reason: potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-30
- Terminated
- 2021-08-04
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.