Recall Z-2289-2020 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
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.
| Date | Jun 5, 2020 (initiated Apr 30, 2020) |
| Status | Terminated |
| Reason | potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. |
| Root cause | Under Investigation by firm |
| Action | The firm notified the service engineers of the issue and the risk to health (exposure to legionella) by email on 04/30/2020. The firm followed with a letter disseminated on 05/12/2020 to customers and service engineers which discussed the hazard and Elekta's updated preventative maintenance. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192482 | Elekta Unity Elekta Limited, Dec 5, 2019 |