Recall record at a glance
| Official record | Z-0734-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Accuray Inc. |
| Report date | Dec 21, 2016 |
| Recall initiation date | Nov 22, 2016 |
| Quantity | 40 affected devices |
| Location | Sunnyvale, CA, United States |
Official product description
CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System 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
Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with software version 1 0.6.
Distribution information
Worldwide Distribution - US Distribution to the states of : PA, WA, MT, NY, SC, CA, MN, AK, NJ, FL, KY, WI., and to the countries of : Bulgaria, Canada, France, Germany, India, Japan, Luxembourg, Netherlands, Portugal, Switzerland and Turkey
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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