Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26669 |
| Brand Name: | Infinity Acute Care System Monitoring - M540 |
| Model: | |
| Affected: | Software version VG7.1 |
| Software version: | |
| Recalling Organisation: | Draeger New Zealand Ltd Unit 4 24 Bishop Dunn Place East Tamaki Auckland 2013 |
| Contact Information: | 0800 559 186 |
| Manufacturer: | Draegerwerk AG & Co KGaA |
| Brand Name: | INFINITY Patient Monitors & Accessories |
| Model: | |
| Affected: | Software version VG7.1 |
| Software version: | |
| Recalling Organisation: | Draeger New Zealand Ltd Unit 4 24 Bishop Dunn Place East Tamaki Auckland 2013 |
| Contact Information: | 0800 559 186 |
| Manufacturer: | Draeger Medical Systems Inc |
| Issue: | Through post market activities the manufacturer has observed issues on the Drager Infinity Acute Care System (IACS) with software version VG7.1; and Infinity M540 Stand Alone Patient Monitor with software version VG7.1. 1. The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. 2. The Infinity Acute Care System Cockpit may lose the ability to send commands to the Infinity M540 Patient Monitor. 3. The Infinity Acute Care System Patient Monitor may exhibit a loss of configuration of the patient and system profile due to disconnection from the internal database after power up of the Cockpit. If this problem is present, it will impact patient category, patient name, patient bed name, network settings, trends, and the units of measure. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/10/2020 |
