FDA Device recall Z-1109-2019
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation…
- FDA Device
- Class II
- terminated
- Published 2019-04-17
On 2019-04-17 the FDA classified a Class II recall of Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation… by Elekta, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1109-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-12 |
| Published | 2019-04-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Elekta |
| Distribution | US |
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.
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.
Identifiers
| code_info | Unity Systems: 13553-006/600003, 13371-002/600021, 10817-011/600010, 10562-011/600016, 10719-T03001/600013, 30004070-0…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1109-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.