Recall Z-0888-2011 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charged particle accelerator (such as the Clinac 600C).
| Date | Jan 10, 2011 (initiated Jan 26, 2009) |
| Status | Terminated |
| Reason | Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact. |
| Root cause | Device Design |
| Action | Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations. |
| Quantity | 3 units |
| Distribution | Product was distributed to 3 consignees in Florida and Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc., Jun 8, 2007 |