FDA Device recall Z-1272-2021
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l…
- FDA Device
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for l… by Accuray, citing the set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1272-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-26 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Accuray |
| Distribution | US |
Product
CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Identifiers
| code_info | Product Codes: 019200, 020600, 021831, 022986, 023730, 025000, 027600, 028000, 030000, 031000, 031500, 0660000, 029640-…Product Codes: 019200, 020600, 021831, 022986, 023730, 025000, 027600, 028000, 030000, 031000, 031500, 0660000, 029640-001, 029828-003, 031000-004, 032000-001, 032000-004, 033000-000, 033000-010, 053101-010, 053101-M-000, 053301-010, 053301-M-000, 053401-010, 053401-M-000, 054000-002, 054000-004, 0660000-000, 1010140-000, 1047641-000 Serial Numbers: C0063, C0067, C0008, C0076, C0077, C0085, C0098, C0101, C0112, C0126, C0131, C0135, C0138, C0151, C0155, C0162, C0166, C0172, C0174, C0176, C0177, C0186, C0187, C0188, C0195, C0197, C0200, C0206, C0208, C0211, C0213, C0228, C0231, C0234, C0240, C0242, C0246, C0253, C0263, C0266, C0271, C0239, C0441, C0446, C0447, C0456, C0460, C0464, C0465, C0469, C0472, C0475, C0481, C0506, C0507, C0193, C0241, C0293, C0090, C0092, C0093, C0100, C0103, C0104, C0115, C0117, C0119, C0124, C0130, C0148, C0150, C0153, C0168, C0181, C0182, C0194, C0205, C0226, C0235, C0236, C0244, C0254, C0255, C0258, C0259, C0267, C0268, C0274, C0276, C0280, C0282, C0283, C02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Accuray
- Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer
FDA Device · Class II · 2026-07-08 · Accuray - CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System
FDA Device · Class II · 2025-02-05 · Accuray - Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System
FDA Device · Class II · 2023-09-06 · Accuray - TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radi…
FDA Device · Class II · 2021-01-13 · Accuray
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1272-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.