Recall Z-0554-2008 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
| Date | Jan 29, 2008 (initiated Sep 26, 2007) |
| Status | Terminated |
| Reason | Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered |
| Root cause | Software design |
| Action | Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available. |
| Quantity | 59 units |
| Distribution | Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063270 | RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Inc., Dec 14, 2006 |