FDA Device recall Z-1696-2019
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c)…
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c)… by Accuray, citing there is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1696-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-10 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Accuray |
| Distribution | n/a |
Product
CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS
Reason
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Identifiers
| code_info | a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C04…a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C0444, C0445, C0446, C0447, C0448, C0449, C0450, C0453, C0454, C0456, C0457, C0458, C0460, C0464, C0465, C0466, C0472, C0475 b) 053101-010: CyberKnife M6 FI Treatment Delivery System Serial Numbers: C0334, C0381 c) 053201-010: CyberKnife M6 FM Treatment Delivery System Serial Numbers: C0363 d) 053301-010: CyberKnife M6 FIM Treatment Delivery System Serial Numbers: C0337, C0343, C0349, C0352, C0358, C0370, C0371, C0378, C0384, C0387, C0389, C0390, C0391, C0393, C0409, C0424, C0426, C0427, C0428, C0433, C0439 e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System Serial Numbers: C0330, C0332, C0342, C0344, C0345, C0348, C0359, C0360, C0364, C0367, C0372, C0394, C0398, C0400, C0402, C0404, C0415, C0419 f) 053501-010: CyberKnife Matrix Tier F TDS Serial Numbers: C0396 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1696-2019%22
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