Elekta Unity Radiation Therapy System Recalled for Heating Issues
Elekta, Inc. is recalling 21 Unity Image-Guided Radiation Therapy Systems due to reports of excessive heating in the MRL Gradient Connection Module.
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 high-risk medical device with a reported defect (excessive heating) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Elekta, Inc. is recalling 21 units of the Elekta Unity, Image-Guided Radiation Therapy System. The recall was initiated due to reports of excessive heating in the MRL Gradient Connection Module.
The affected devices are distributed in the United States (Pennsylvania, New York, and Iowa) and internationally in Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, the Netherlands, Sweden, Thailand, Turkey, and the United Kingdom. There was no government or military distribution.
The specific serial numbers for the recalled devices are 600014, 600016, 600017, 600018, 600019, 600020, 600021, 600022, 600023, 600024, 600025, 600026, 600027, 600028, 600029, 600030, 600031, 600032, 600033, 600034, and 600035. Users should contact Elekta, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Elekta Unity, Image-Guided Radiation Therapy System
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 21
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)
- Elekta Unity Serial numbers 600014
- 600016
- 600017
- 600018
- 600019
- 600020
- 600021
- 600022
- 600023
- 600024
- 600025
- 600026
- 600027
- 600028
- 600029
- 600030
- 600031
- 600032
- 600033
- 600034
Distribution
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