Reported Nov 14, 2018 · Terminated
CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided…
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 M6, Part Number 054000-004 The CyberKnife M6 Systems are 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.
- Lot codes and dates
- Serial Numbers
93 of 93 codes
C0330C0332C0334C0335C0336C0337C0338C0342C0343C0344C0345C0346C0348C0349C0351C0352C0354C0356C0358C0359C0360C0361C0363C0364C0366C0367C0368C0369C0370C0371C0372C0373C0374C0376C0378C0379C0380C0381C0383C0384C0387C0389C0390C0391C0393C0394C0395C0396C0397C0398C0400C0402C0404C0407C0408C0409C0410C0411C0413C0414
- Serial Numbers
- Amount recalled
- 93 units
Why it was recalled
A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.
This product could cause temporary or reversible health problems — stop using it.
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