Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27836 |
| Brand Name: | Avalon Fetal Monitors |
| Model: | Philips Avalon Fetal Monitors FM20/FM30/FM40/FM50 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Philips New Zealand Commercial Limited Level 3 123 Carlton Gore Road Newmarket AUCKLAND 1023 |
| Contact Information: | 0800 251 400 |
| Manufacturer: | Philips Medizin Systeme Boblingen GmbH |
| Issue: | The manufacturer has identified a software anomaly in the affected Fetal Monitors that can lead to any of the following reporting issues when generating a non-stress test (NST) report according to the Dawes & Redman algorithm: 1. Instead of the average baseline value, the maximum baseline value is printed on the NST report. 2. Delayed generation of a criteria met report. 3. A criteria not met report is generated instead of a criteria met report. Reviewing the incorrect report can lead to misinterpreting the NST report. Patient harm is not expected to occur. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/6/2021 |
