Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues
Elekta Limited is recalling 12 Unity MRI-guided radiation therapy systems because acquired images may not represent average anatomy during respiratory motion, potentially affecting treatment accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where the hazard (inaccurate anatomical imaging during respiratory motion) poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Elekta Limited is recalling 12 units of the Elekta Unity, Image-Guided Radiation Therapy System. The recall is due to issues with specific scan protocols used for daily online plan adaptation. The images acquired using these protocols are based on data acquired around full expiration and do not represent the average position of the anatomy during the respiratory motion cycle. Additionally, the Elekta Unity Application software does not display information about the protocol used to acquire the image, such as whether respiratory triggering was used.
The affected systems are distributed worldwide, including in the United States (Texas, New York, Wisconsin) and in Denmark, Germany, Italy, the Netherlands, Sweden, and the United Kingdom. The recall number is Z-1109-2019. Specific serial numbers for the affected units are listed in the source metadata.
Users must be aware that the images do not reflect average anatomy during respiratory motion. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan to ensure accurate treatment delivery.
The recalled product
- 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 licens
- Manufacturer
- Elekta Limited
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distribution
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