FDA Device recall Z-0828-2014
Accuray CyberKnife Robotic Radiosurgery System
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Accuray CyberKnife Robotic Radiosurgery System by Accuray, citing potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-13 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Accuray |
| Distribution | US |
Product
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
Reason
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Identifiers
| code_info | Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051…Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051 C0052 C0053 C0055 C0056 C0057 C0058 C0059 C0061 C0062 C0063 C0064 C0067 C0068 C0070 C0071 C0072 C0074 C0078 C0079 C0080 C0088 C0090 C0091 C0092 C0094 C0095 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0108 C0109 C0111 C0112 C0114 C0118 C0119 C0122 C0123 C0126 C0127 C0128 C0131 C0132 C0133 C0134 C0135 C0136 C0137 C0139 C0141 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0160 C0162 C0163 C0165 C0174 C0177 C0178 C0179 C0181 C0182 C0183 C0184 C0186 C0192 C0194 C0196 C0197 C0198 C0199 C0200 C0201 C0203 C0205 C0206 C0207 C0208 C0209 C0210 C0213 C0214 C0219 C0220 C0222 C0223 C0224 C0225 C0226 C0233 C0243 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0257 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2014%22
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