Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24025 |
| Brand Name: | SISS Babycontrol Apnoea Monitor M |
| Model: | PN B00116 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Promed Technologies Ltd Unit B 14-22 Triton Drive Upper Harbour, North Shore Auckland 0632 |
| Contact Information: | |
| Manufacturer: | Schulte-Elektronik GmbH |
| Issue: | The devices can be used both in the home environment, as well as in the hospital sector. However, the monitoring of intensive care patients is not covered by the intended purpose of our devices. Therefore, the manufacturer has provided additional safety information and warnings which are now included in the instructions for use. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/12/2018 |
