Elekta Unity recall
Elekta Unity, Image-Guided Radiation Therapy System
Why was Elekta Unity recalled?
There have been reports of excessive heating in the MRL Gradient Connection Module.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Elekta Unity, Image-Guided Radiation Therapy System
- Recalling firm
- Elekta, Inc.
- Quantity
- 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.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)