Recall Z-0117-2009 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.
| Date | Oct 20, 2008 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers. |
| Root cause | Device Design |
| Action | Recall initiated on 08/11/2008. Notification will be sent to Varian Sales, Marketing and Service organizations as well as to all affected users. Contact Varian Medical Systems Oncology Systems, at 1-650-424-5731 for assistance. |
| Quantity | 3296 units |
| Distribution | Worldwide including to the US and to Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, United Kingdom, Alger |
| FDA record | Open on fda.gov |