Leksell Gamma Knife recalled over adapter not properly aligned or locked
Elekta is recalling Leksell Gamma Knife radiosurgery systems, covering the Perfexion, Icon and Elekta Esprit models, due to an adapter not being properly aligned or locked in place.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an adapter that is not properly locked on a radiosurgery system is a hazard during treatment, and no injuries are stated.
Plain-English summary
Elekta, Inc. is recalling the Leksell Gamma Knife, covering the Perfexion, Icon and Elekta Esprit models. The Leksell Gamma Knife is a radiosurgery system used in the stereotactic irradiation of head structures, delivering a prescribed dose as one or more shots of ionizing radiation to the target site. About 352 units were distributed across 37 US states and Puerto Rico and to more than fifty other countries. The FDA has classified this recall as Class II.
The recall was initiated due to an adapter not being properly aligned or locked in place.
Affected systems are listed by product and serial number in the FDA enforcement record.
Facilities can identify affected systems by the model and serial number, and may contact Elekta, Inc. for further information.
The recalled product
- Product
- Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereot
- Manufacturer
- Elekta, Inc.
- Category
- Medical Device — Radiosurgery
- Affected units
- 352
Distribution
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