Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Software Upgrade Issue
Accuray is recalling 84 CyberKnife Robotic Radiosurgery Systems to correct a potential safety issue related to upgrading the Treatment Delivery Software for the first generation IRIS Variable Aperture Collimator.
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 is classified as FDA Class II and involves a potential safety issue in a medical device used for radiation therapy. No specific injuries or illnesses are reported in the source text, but the risk of harm from a software defect in a high-risk medical device warrants a High severity rating.
Plain-English summary
Accuray Incorporated is recalling 84 CyberKnife Robotic Radiosurgery Systems equipped with the first generation IRIS Variable Aperture Collimator. The recall is initiated to correct a potential safety issue that occurs when upgrading the Treatment Delivery Software for this specific collimator model.
The affected devices are distributed worldwide, including in the United States and various foreign countries such as Canada, Germany, France, and India. The recall involves a software upgrade to address the identified safety concern.
Healthcare facilities and users of the affected devices should contact Accuray Incorporated to arrange for the necessary software correction. The recall number is Z-0218-2015.
The recalled product
- Product
- CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body…
- Manufacturer
- Accuray Incorporated
- Affected units
- 84
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)
- Catalog/Part number 054000-0001
Distribution
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