FDA Device recall Z-0771-2016
CyberKnife Robotic
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of CyberKnife Robotic by Accuray, citing the gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0771-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-22 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accuray |
| Distribution | US |
Product
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is 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.
Reason
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
Identifiers
| code_info | Catalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C00…Catalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C0092 C0095 C0096 C0098 C0099 C0100 C0101 C0102 C0103 C0104 C0106 C0108 C0111 C0112 C0114 C0118 C0119 C0123 C0126 C0127 C0128 C0131 C0133 C0134 C0135 C0136 C0137 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0162 C0163 C0165 C0172 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 C0224 C0226 C0233 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0328 C0353 C0355 C0124: International: C0170 C0171 C0180 C0216 C0236 C0264 C0269 C0326 C0204 C0125 C0175 C0189 C0191 C0215 C0227 C0279 C0315 C0166 C0147 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0771-2016%22
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