| 2026-06-16 |
Class II
|
Ongoing |
Z-2644-2026 |
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator |
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In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the … |
| 2026-06-16 |
Class II
|
Ongoing |
Z-2640-2026 |
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator |
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In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the … |
| 2024-12-23 |
Class II
|
Completed |
Z-1023-2025 |
CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R… |
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Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll … |
| 2023-08-03 |
Class II
|
Completed |
Z-2489-2023 |
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. |
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It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for mo… |
| 2021-02-26 |
Class II
|
Terminated |
Z-1272-2021 |
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision… |
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The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll. |
| 2020-12-10 |
Class II
|
Terminated |
Z-0785-2021 |
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and preci… |
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"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |
| 2020-12-10 |
Class II
|
Terminated |
Z-0784-2021 |
TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radi… |
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"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose. |