The Recall Desk
SevereFDA (Devices)·Z-1126-2013·Announced 2013-04-24

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Radiation Therapy
Hazard
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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