Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18576 |
| Brand Name: | Respironics BiPAP Unit |
| Model: | BiPAP AutoSV, BiPAP AutoSV Advanced |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | Care Medical Ltd |
| Contact Information: | 0800 333 444 |
| Manufacturer: | Respironics Inc |
| Issue: | A clinical trial has indicated an increased risk of death for patients with a specific heart condition if they are being treated with Adaptive ServoVentilation (ASV) mode on ResMed ventilators. As a result, Respironics is updating the instructions for use to change the intended use statement and add a contraindication for patients with the specific heart condition. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/6/2015 |
