Elekta Synergy XVI Radiation Therapy System Recalled for Collision Risk
Elekta, Inc. is recalling 312 Synergy XVI radiation therapy systems due to a potential collision risk when used with external beam shaping devices.
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 (radiation therapy equipment) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Elekta, Inc. is recalling 312 units of the Synergy XVI radiation therapy system. The recall is due to a potential collision risk that may occur when the device is used with external beam shaping devices. The Synergy XVI is intended for the radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
The affected units are identified by Model 4.2.1. These devices were distributed nationwide in the United States, including Puerto Rico, and internationally to numerous countries including Canada, the United Kingdom, Germany, and Japan.
Consumers and healthcare facilities should contact Elekta, Inc. for further information regarding this recall and any necessary corrective actions.
The recalled product
- Product
- Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 312
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 4.2.1
Distribution
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