Recall Z-1109-2019 ยท IYE Accelerator, Linear, Medical
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 Treat
| Date | Mar 12, 2019 |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182076 | Elekta Unity Elekta Limited, Dec 4, 2018 |