Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15809 |
| Brand Name: | Elekta X-Ray Volume Imaging System (XVI) |
| Model: | |
| Affected: | |
| Software version: | R4.5, R4.5.1, R4.6 to R5.0 |
| Recalling Organisation: | Elekta Pty Limited - New Zealand Branch Suite 302, Geyser Building, 100 Parnell Road Parnell AUCKLAND 1052 |
| Contact Information: | 0273-544-793 |
| Manufacturer: | Elekta Limited (England) |
| Issue: | The Xray Volume Imaging System (XVI) can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently. If patient and treatment table movements are not monitored ,and the automatic setup buttons are kept pressed ,the treatment table continues to move. It only stops when a touchguard activates. Therefore this error can cause a collision between the patient and an external beam limiting device. If this error occurs with an external beam limiting device attached to the digital accelerator, it may cause fatal injury to the patient. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/10/2014 |
