The Recall Desk
HighFDA (Devices)·Z-1083-2014·Announced 2014-03-12

Elekta Integrity Software Recalled for Calibration Input Errors

Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.

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 high-risk medical device where a software defect could lead to incorrect calibration, representing a risk of harm even though no injuries have been reported.

Plain-English summary

Elekta, Inc. is recalling Integrity Version 1.1, an interface and control software used for the Elekta range of medical digital linear accelerators. The recall involves 455 units distributed worldwide, including the United States and numerous international locations.

The recall was initiated because it is possible to type incorrect values or invert a value during the treatment table, gantry, and collimator calibration procedures. This potential for data entry error could affect the accuracy of the equipment's calibration.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.

The recalled product

Product
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Manufacturer
Elekta, Inc.
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
455

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)

  • Model 1.1

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Elekta, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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