| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00371-1 |
| Product Name/Description |
RPM Respiratory Gating System, version v1.7.5 with 3D Option (Patient respiratory monitoring system used with radiation therapy systems)
Product code: H50
Multiple serial numbers affected
ARTG Number: 117951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions. The error may be reproduced if the RPM System is induced to frequently lose and reacquire tracking of the 6-dot marker block during a calibration sequence, a reference session or a single session after tracking has begun. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is providing temporary work around instructions and is implementing a software update to permanently correct the problem. |
| Contact Information |
1800 657 036 - Varian Oncology Helpdesk |