Accuray CyberKnife Robotic Radiosurgery System Recall for Mounting Assembly Issue
Accuray is recalling 302 CyberKnife systems worldwide due to a potential safety issue where the Synchrony Boom Arm Mounting Assembly may detach.
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 with a reported mechanical failure (detachment) that poses a risk of harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 302 units of the Accuray CyberKnife Robotic Radiosurgery System. The recall is due to a potential safety issue with the Synchrony Boom Arm Mounting Assembly, which has been reported to detach in one instance. The affected devices are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
The recall affects 149 devices in the United States and 153 devices outside the United States. The devices were distributed worldwide, including in the US, Mexico, and numerous international locations such as Australia, Canada, China, and the United Kingdom. The specific part number for the affected assembly is 054000-001.
Accuray Incorporated is the recalling firm. The source text does not specify the corrective action or instructions for consumers or healthcare providers regarding the recall.
The recalled product
- Product
- Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
- Manufacturer
- Accuray Incorporated
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)
- Part number: 054000-001
Distribution
Distributed nationwide across the United States.
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