Reported Apr 17, 2019 · Terminated
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is…
Elekta Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Limited · Linac House · Crawley, N/A · N/A
Is this the product you have?
- Elekta Unity, Image-Guided
- Radiation Therapy System Product UsageElekta 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
- Lot codes and dates
- Unity Systems
13553-006/60000313371-002/60002110817-011/60001010562-011/60001610719-T03001/60001330004070-001/60002310420-AVL-U/60000811014-UMCU-U/60000710157-006/60001411611-40/60001130001461-J001/60000211489-21/600009
- Unity Systems
- Amount recalled
- 12 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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