FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Elekta Unity, Image-Guided Radiation Therapy System
- Recall number
- Z-2473-2020
- Recalling firm
- Elekta, Inc.
- Product
- Elekta Unity, Image-Guided Radiation Therapy System
- Status
- Terminated
- Initiated
- 2019-12-18
- Posted
- not on file
- Terminated
- 2021-06-15
- Reason
- There have been reports of excessive heating in the MRL Gradient Connection Module.
- Root cause
- Process control
- Action
- Initially, the firm issued an email on 12/18/2019 to their field engineers which said they had attached a "Knowledge Article" which provided instructions on how to inspect the Philips Marlin 1.5T system used in the Elekta Unity MR Linac. On 5/11/2020, the firm issued an Urgent Important Field Safety Notification dated May, 2020, via email to consignees which explained the problem, clinical impact, and said that initial corrective actions have been performed on all impacted sites to ensure the gradient coil connection assembly is correct. It goes onto say that extensive testing of the incorrect connection material has been completed to ensure that continued use of the Elekta Unity system is acceptable, however, it remained that further actions can be taken to reduce the risk.
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K192482"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28