Recall Z-1460-2008 ยท KPQ System, Simulation, Radiation Therapy
Varian Medical Systems Oncology Systems
Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77.
| Date | Jul 30, 2008 (initiated Jan 3, 2008) |
| Status | Terminated |
| Reason | Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view. |
| Root cause | Software design |
| Action | Consignees were notified by an Urgent Medical Device Correction letter issued on 02/05/2008. The letter provided recommended actions for users to follow in order to avoid the software error. The letter informed users that a service pack is being created to correct the issue and that the recalling firm will notify users when it becomes available. For additional information, contact 888-827-4265. |
| Quantity | 16 UNITS |
| Distribution | Worldwide Distribution--USA including states of CA, MA and PA, and countries of UK, Chile, Belgium, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033339 | ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY Varian Medical Systems, Inc., Dec 30, 2003 |