Accuray Recalls CyberKnife M6 Systems Due to Wrist Component Failure Risk
Accuray is recalling 93 CyberKnife M6 systems worldwide due to manufacturing variations in the robot wrist that may cause premature component failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device where a component failure could lead to harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 93 units of the CyberKnife M6 system, Part Number 054000-004. These systems are indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
The recall was initiated after a robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. These variations may result in premature failure of the component.
The affected units were distributed worldwide. Specific serial numbers for the recalled units are listed in the official recall documentation. Users of these systems should contact Accuray Incorporated for further instructions regarding the recall and potential remediation.
The recalled product
- Product
- CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Manufacturer
- Accuray Incorporated
- Hazard
- Affected units
- 93
Distribution
Distribution scope not specified by the agency.
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