Elekta Unity Systems Recalled for Missing Contrast Agent Warnings
Elekta Limited is recalling nine Elekta Unity systems because the user manual lacks a warning regarding the administration of unvalidated contrast agents.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a documentation issue (missing warning) without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling/documentation error.
Plain-English summary
Elekta Limited is recalling nine Elekta Unity systems. These devices are indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body. The recall is due to a documentation deficiency in the product manual.
The Elekta Unity manual does not include a warning that the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. This omission may lead to the use of unvalidated contrast agents during treatment.
The affected devices were distributed worldwide, including in the United States (Texas and Wisconsin) and internationally to Denmark, England, Germany, Italy, and the Netherlands. Users should contact Elekta Limited for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Elekta Unity systems 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 acco
- Manufacturer
- Elekta Limited
- Affected units
- 9
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 (11)
- Product Code: UNITY SYSTEM/13553-006/600003
- UNITY SYSTEM/10817-011/600010
- UNITY SYSTEM/10562-011/600016
- UNITY SYSTEM/10719-T03001/600013
- UNITY SYSTEM/30004070-001/600023
- UNITY SYSTEM/10420-AVL-U/600008
- UNITY SYSTEM/11014-UMCU-U/600007
- UNITY SYSTEM/11611-40/600011
- UNITY SYSTEM/11489-21/600009
- UDI: 1536549
- 1536549
Distribution
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