Elekta Digital Accelerator Recall for Potential Uncontrolled Detector Arm Extension
Elekta is recalling 2,998 Digital Accelerators worldwide due to a potential for uncontrolled extension of iViewGT or XVI detector arms.
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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential physical injury from uncontrolled movement.
Plain-English summary
Elekta, Inc. is recalling 2,998 units of ELEKTA Digital Accelerators, sold under brand names including Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD. The recall affects all Digital Accelerators equipped with XVI or iViewGT systems.
The recall is being conducted because there is a potential for an uncontrolled extension of the iViewGT or XVI detector arms. This defect could pose a risk of harm to patients or operators if the arms move unexpectedly.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Users of these devices should contact Elekta, Inc. for instructions on how to address the potential defect.
The recalled product
- Product
- ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
- Manufacturer
- Elekta, Inc.
- Affected units
- 2,998
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)
- All Digital Accelerators with XVI or iViewGT
Distribution
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