Elekta Unity, Image-Guided Radiation Therapy System
Reported: July 8, 2020 Initiated: December 18, 2019 #Z-2473-2020
Product Description
Elekta Unity, Image-Guided Radiation Therapy System
Reason for Recall
There have been reports of excessive heating in the MRL Gradient Connection Module.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 21 devices
- Distribution
- Distributed in US - PA, NY, and IA. Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK. There was no government/military distribution.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Elekta Unity, Image-Guided Radiation Therapy System. Recalled by Elekta, Inc.. Units affected: 21 devices.
Why was this product recalled? ▼
There have been reports of excessive heating in the MRL Gradient Connection Module.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2473-2020.
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