Recall Z-3204-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.
| Date | Sep 14, 2011 (initiated Mar 17, 2011) |
| Status | Terminated |
| Reason | An improperly installed collimator cover may detach and fall from the machine, potentially striking the patient or nearby personnel. |
| Root cause | Component design/selection |
| Action | On 3/17/2011, Varian Medical Systems sent an Urgent Medical Device Correction Letter to all affected users, with a description of the problem and user corrective action steps. |
| Quantity | 3791 units |
| Distribution | Worldwide distribution including USA, Australia, Argentina, Italy, Morocco, South Korea, Belgium, Canada, Netherlands, Denmark, Japan, Hong Kong, Malaysia, Hungary, New Zealand, Sweden, Taiwan, Switzerland, Romania, Brazil, Slovakia, India, Colombia, UK, Ireland, Spain, Singapore, Martinique, Reunio |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100890 | VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Jul 13, 2010 |