Accuray CyberKnife Treatment Delivery System Recalled for Loose Set Screws
Accuray is recalling 243 CyberKnife Treatment Delivery Systems because set screws can loosen, allowing the treatment couch to roll unexpectedly.
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 medical device with a mechanical defect that could cause the treatment couch to roll, posing a risk of harm to patients and staff. The source text does not report any injuries or illnesses, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Accuray Incorporated is recalling 243 units of the CyberKnife Treatment Delivery System. The recall is due to a defect where the set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time. This loosening allows the couch to roll, which poses a risk to patients and staff during image-guided stereotactic radiosurgery and precision radiotherapy procedures.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. The recall includes specific product codes and serial numbers listed in the official FDA documentation. No specific dates of distribution or installation are provided in the source text.
Healthcare facilities using these systems should contact Accuray Incorporated for instructions on how to address the defect. Patients who have received treatment on these devices should consult their healthcare providers if they have concerns about the stability of the equipment during their sessions.
The recalled product
- Product
- CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
- Manufacturer
- Accuray Incorporated
- Affected units
- 243
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 (20)
- Product Codes: 019200
- 020600
- 021831
- 022986
- 023730
- 025000
- 027600
- 028000
- 030000
- 031000
- 031500
- 0660000
- 029640-001
- 029828-003
- 031000-004
- 032000-001
- 032000-004
- 033000-000
- 033000-010
- 053101-010
Distribution
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