Reported Mar 24, 2021 · Terminated
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and…
Accuray Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accuray Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
- CyberKnife Treatment
- Delivery System - Product Usageindicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated
- Lot codes and dates
- Product Codes
0192000206000218310229860237300250000276000280000300000310000315000660000029640-001029828-003031000-004032000-001032000-004033000-000033000-010053101-010053101-M-000053301-010053301-M-000053401-010053401-M-000054000-002054000-0040660000-0001010140-0001047641-000
- Serial Numbers
243 of 243 codes
C0063C0067C0008C0076C0077C0085C0098C0101C0112C0126C0131C0135C0138C0151C0155C0162C0166C0172C0174C0176C0177C0186C0187C0188C0195C0197C0200C0206C0208C0211C0213C0228C0231C0234C0240C0242C0246C0253C0263C0266C0271C0239C0441C0446C0447C0456C0460C0464C0465C0469C0472C0475C0481C0506C0507C0193C0241C0293C0090C0092
- Product Codes
- Amount recalled
- 243 units
Where it was sold
Why it was recalled
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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