Recall record at a glance
| Official record | Z-0218-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Accuray Inc. |
| Report date | Nov 26, 2014 |
| Recall initiation date | Oct 31, 2014 |
| Quantity | 84 devices subject to correction. |
| Location | Sunnyvale, CA, United States |
Official product description
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 when radiation treatment is indicated.
Why the product was recalled
Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
Distribution information
Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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