Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18175 |
| Brand Name: | Dameca Anaesthesia systems |
| Model: | IntelliSave AX700 (866205/10623-00), Dameca MRI508 (866203/10651MRI-00), Siesta iWhispa (866202/10651-00), Siesta iTS (866163/10653-00), Siesta Breasy (866204/10652-00) |
| Affected: | Multiple serial numbers affected |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Dameca A/S |
| Issue: | The spring-function of the control dial may not work, which may cause the control dial to get stuck when pushed, thus preventing its normal and expected function. It can be brought up to working condition again by simply pulling it out. The control dial is part of the user interface and serves an important role in setting and controlling the anaesthesia machine functions as it is used to adjust and confirm settings made by the user. For Siesta i Breasy, Siesta i Whispa and MRI 508 freshgas regulation and ventilator mode change (Manual or Ventilator) can still be done as this is mechanical and/or soft key controlled and doesn't need confirmation by the control dial. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Sponsor Control |
| Date Commenced: | 6/3/2015 |
