FDA Medical Device Recalls (openFDA)
Elekta Limited: Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
- Recall number
- Z-1109-2019
- Recalling firm
- Elekta Limited
- Product
- Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging 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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
- Status
- Terminated
- Initiated
- 2019-03-12
- Posted
- not on file
- Terminated
- 2023-11-03
- Reason
- Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
- Root cause
- Software design
- Action
- The firm issued a field safety notice on 03/12/2019 by email. The notice explained the issue and cautioned the consignee to select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
- Quantity
- 12 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom
- Lot, serial or model codes
- Unity Systems: 13553-006/600003, 13371-002/600021, 10817-011/600010, 10562-011/600016, 10719-T03001/600013, 30004070-001/600023, 10420-AVL-U/600008, 11014-UMCU-U/600007, 10157-006/600014, 11611-40/600011, 30001461-J001/600002, 11489-21/600009,
- 510(k) numbers
- K182076
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3002806900
- Firm city
- Crawley
- Firm state
- not on file
- Firm country
- United Kingdom
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