Recall Z-0978-2007 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.
| Date | Jun 28, 2007 (initiated Mar 9, 2007) |
| Status | Terminated |
| Reason | A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation. |
| Root cause | Software design |
| Action | The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer. |
| Quantity | 80 devices |
| Distribution | The medical devices were distributed to medical centers nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.