Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation ther
FDA device recall Z-2289-2020 · posted 2020-06-05 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- IYE
- Quantity 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, Netherland
- Date initiated
- 2020-04-30
- Date posted
- 2020-06-05
- Date terminated
- 2021-08-04
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elekta Unity (K192482) | Elekta Limited | 2019-12-05 |