Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for rad...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1109-2019.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1109-2019.
Recall terminated by FDA.
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- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1109-2019.
Elekta Limited
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Elekta Limited Recall FAQ
Elekta Limited is the subject of a medical devices safety report: Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for rad.... The notice was published on March 12, 2019 by the U.S. Food and Drug Administration (FDA). Approximately 12 units are potentially affected.