Elekta Integrity Software Recalled for Incorrect Radiation Beam Delivery Tolerances
Elekta, Inc. is recalling Integrity 1.1 software because it uses static calibration tolerances instead of calculated values for radiation delivery.
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 3/5 (High).
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 lead to incorrect radiation delivery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 498 units of Integrity 1.1 software, which serves as the interface and control system for Elekta medical digital linear accelerators. The software is intended to assist licensed practitioners in delivering radiation to defined target volumes.
The recall is due to a defect where the software uses "static tolerances" from calibration files for beam delivery instead of the machine-calculated values. This discrepancy could affect the accuracy of radiation delivery.
The affected software was distributed worldwide, including in the United States and numerous international countries. Healthcare facilities using Elekta linear accelerators with this specific software version should contact Elekta for further instructions on remediation.
The recalled product
- Product
- Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
- Manufacturer
- Elekta, Inc.
- Affected units
- 498
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 (20)
- 152718
- 152003
- 152007
- 151963
- 152081
- 151693
- 152131
- 152318
- 105792
- 105570
- 152778
- 151052
- 152363
- 152472
- 152195
- 153022
- 152689
- 152640
- 152642
- 152663
Distribution
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