Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1 Recalled by Elekta, Inc. Due to The DICOM tags do not contain sufficient information...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta, Inc. directly.
Affected Products
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Quantity: 164
Why Was This Recalled?
The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Elekta, Inc.
Elekta, Inc. has 100 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report