Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1297-2019·Announced 2019-05-15

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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…
Manufacturer: Elekta Limited
Category: Medical Device — Radiation Therapy
Hazard: mis-labeling
documentation-deficiency
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

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Elekta Limited

See all →

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FDA (Devices) · 2020-06-17
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Elekta Unity MRI Radiation Therapy System Recalled for Image Protocol Issues
FDA (Devices) · 2019-04-17
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Elekta Unity MRI Speakers May Become Dislodged and Enter Bore
FDA (Devices) · 2019-01-16
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Elekta Integrity R1.2 Medical Device Recalled for Positional Error Risk
FDA (Devices) · 2018-03-07
High
Elekta Agility with Integrity R3.2 Software Recall for Positional Errors
FDA (Devices) · 2018-03-07

Same hazard · mis labeling