Device product
Elekta Unity, Image-Guided Radiation Therapy System
Z-2473-2020
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 85620
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 devices
- Official record key
device-enforcement:Z-2473-2020
Official wording
Reason: There have been reports of excessive heating in the MRL Gradient Connection Module.
Code information: Elekta Unity Serial numbers 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, 600035
Distribution pattern: 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.
Derived failure modes
-
Unknown
There have been reports of excessive heating in the MRL Gradient Connection Module.