Reported Feb 17, 2016 · Terminated

CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic…

Accuray Incorporated

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accuray Incorporated · 1310 Chesapeake Ter · Sunnyvale, CA · 94089-1100

Is this the product you have?

  • CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package
  • Product UsageThe 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
Lot codes and dates
  • Catalog/part numbers 032000 and 033000
  • Serial numbersUnited
  • States

    105 of 105 codes

    • 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
  • C0316 C0323 C0328 C0353 C0355 C0124International:

    115 of 115 codes

    • C0170
    • C0171
    • C0180
    • C0216
    • C0236
    • C0264
    • C0269
    • C0326
    • C0204
    • C0125
    • C0175
    • C0189
    • C0191
    • C0215
    • C0227
    • C0279
    • C0315
    • C0166
    • C0147
    • C0168
    • C0187
    • C0105
    • C0242
    • C0185
    • C0286
    • C0306
    • C0188
    • C0218
    • C0237
    • C0240
    • C0265
    • C0268
    • C0288
    • C0314
    • C0324
    • C0251
    • C0272
    • C0322
    • C0153
    • C0289
    • C0235
    • C0267
    • C0120
    • C0138
    • C0148
    • C0157
    • C0212
    • C0229
    • C0239
    • C0297
    • C0241
    • C0281
    • C0300
    • C0307
    • C0308
    • C0313
    • C0320
    • C0327
    • C0329
    • C0331
Amount recalled
226

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 20, 2016 · Data as of Sep 19, 6:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.