Accuray CyberKnife VSI Robotic Radiosurgery Systems Recalled for Collimator Housing Drop
Accuray is recalling 43 CyberKnife VSI systems because an interlock interruption during automated housing exchange can cause the secondary collimator housing to drop.
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 high-risk medical device with a mechanical defect that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Accuray Incorporated is recalling 43 units of the CyberKnife VSI Robotic Radiosurgery System. The affected part numbers are 032500-010 (CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan) and 033000-010 (CyberKnife VSI Robotic Radiosurgery System). The recall covers specific serial numbers listed in the agency's structured data.
The recall is due to a potential unintended drop of the secondary collimator housing. This can occur during automated housing Xchange workflows if an interlock interrupts the operation, causing the collimator housing to only partially attach. The affected units were distributed in the US, Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, and Thailand.
Healthcare facilities and users of these systems should contact Accuray Incorporated for instructions on how to address the defect. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
- Manufacturer
- Accuray Incorporated
- Affected units
- 43
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)
- C0064
- C0071
- C0074
- C0079
- C0091
- C0098
- C0102
- C0137
- C0161
- C0180
- C0182
- C0187
- C0200
- C0203
- C0210
- C0216
- C0230
- C0238
- C0246
- C0247
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Accuray Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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