Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift
Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect in a radiation therapy device that could shift the beam axis, posing significant clinical impact and potential for serious injury.
Plain-English summary
Accuray Incorporated is recalling 176 units of the Iris Variable Aperture Collimator (P/Ns 028986 and 031777) used in the CyberKnife System. The CyberKnife System is a robotic radiosurgery system indicated for radiation treatment. The recall covers all units of these specific models.
The recall is due to a defect on the master-side connector block of the pneumatic tool changer. This defect could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to treatment plans created using the smallest collimators.
The affected units were distributed worldwide, including in the United States and in Korea, Myanmar, Canada, Belgium, England, Czech Republic, Finland, France, Germany, Greece, India, Italy, Poland, Russia, Spain, Switzerland, Turkey, Columbia, Mexico, Japan, and Saudi Arabia. Healthcare providers and facilities using these devices should contact Accuray Incorporated for instructions on how to address the defect.
The recalled product
- Product
- Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
- Manufacturer
- Accuray Incorporated
- Affected units
- 176
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)
- All units of these models.
Distribution
Distributed nationwide across the United States.
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