Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 14570 |
| Brand Name: | Varian RPM Respiratory Gating System |
| Model: | H50 |
| Affected: | 1.7.5 with 3D option SN's: H501056, H501080, H501944, H502289, H502300, H502301, H503567, H503596, H503935, H504201 and H504724. |
| Software version: | |
| Recalling Organisation: | Varian Medical Systems Australasia Pty Ltd (NZ) Millenium Centre, Level 3, Building C, 600 Great South Road Ellerslie Auckland 1051 |
| Contact Information: | 0800 486 732 |
| Manufacturer: | Varian Medical Systems Inc |
| Issue: | Manufacturer has identified an anomaly with the RPM Respiratory gating System. While operating with the 6-dot marker block, this version of the 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 re-acquire tracking of the 6-door marker block during a calibration sequence, a reference session or a single session after tracking has begun. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/4/2013 |
