Recall Z-0213-2008 ยท KPQ System, Simulation, Radiation Therapy
Varian Medical Systems Inc
Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
| Date | Nov 8, 2007 (initiated Jun 25, 2007) |
| Status | Terminated |
| Reason | Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur. |
| Root cause | Software design |
| Action | The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem. |
| Quantity | 14 units |
| Distribution | Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.--- |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851653 | VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP Varian Assoc., Inc., May 23, 1985 |