CLASS II Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy recalled
Elekta is recalling Elekta Unity, distributed nationwide in the US. The recall was initiated on 30 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2289-2020
- FDA event ID
- 85651
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2020
- FDA classified
- 5 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Apr 2020 | Recall initiated by company | |
| 5 Jun 2020 | Classified by FDA | +36 days |
| 17 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide IowaNew JerseyNew YorkPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Is Elekta Unity, UDI 05060191071321, Image-guided radiation therapy recalled?
Yes. Elekta recalled Elekta Unity, UDI 05060191071321, Image-guided radiation therapy on 30 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2289-2020.
Why was it recalled?
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
Which lots are affected?
Serial numbers 600001 - 600043
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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