Elekta Synergy XVI Radiation Therapy Systems Recalled for Table Position Errors
Elekta, Inc. is recalling Synergy XVI radiation therapy systems because they may incorrectly calculate the treatment table's target position.
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 used for radiation therapy where a calculation error could lead to incorrect treatment delivery. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Elekta, Inc. is recalling 380 Synergy XVI radiation therapy systems in the United States and internationally. The recall affects software versions R4.0 through R4.2.1, R4.5.0, R4.5.1, and R5.0.0 through R5.0.1. The devices are intended for radiation therapy treatment.
The recall was initiated because the Synergy XVI systems can incorrectly calculate the target position of the treatment table. This error could impact the accuracy of the radiation therapy delivery.
The affected units were distributed worldwide, including in the United States (AZ, CT, IA, OH, MD, MI, MN, NV, TX, and VA) and in India, Ireland, Malta, the Netherlands, South Africa, and the UK. Users of these devices should contact Elekta, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Synergy XVI Intended for radiation therapy treatment.
- Manufacturer
- Elekta, Inc.
- Affected units
- 380
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 (4)
- XVI R4.0 to R4.2.1
- R4.5.0
- R4.5.1
- and R5.0.0 to R5.0.1
Distribution
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