The Recall Desk
HighFDA (Devices)·Z-0118-2013·Announced 2012-10-31

Elekta Recalls Oncentra External Beam 4.1 Radiation Treatment Planning Software

Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 software due to a defect that allows beam weights to be changed during dose calculation without error messages.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that could impact radiation treatment planning, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.

Plain-English summary

Elekta, Inc. is recalling 52 units of Oncentra External Beam 4.1 radiation treatment planning software. The software is designed to analyze and plan radiation treatments for patients with cancer. The recall is due to a defect in the planning process where beam weights can be changed and renumbered during dose calculation. In such cases, it is possible to save and reopen the plan without any error messages being displayed.

The affected software was distributed nationwide, including in the states of Alabama, California, the District of Columbia, Kansas, Louisiana, Missouri, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, and Washington. Because the product is software, there are no specific lot codes associated with the recall.

Healthcare facilities using this software should contact Elekta, Inc. for further instructions on how to address the defect. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Manufacturer
Elekta, Inc.
Category
Medical Device — Software
Hazard
Affected units
52

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 (1)

  • None as the product is software

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

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