Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18370 |
| Brand Name: | Philips Ultrasound QLAB 10.0 (on Xcelera) |
| Model: | |
| Affected: | QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins |
| 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 Medical Systems Nederland BV |
| Issue: | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller ESV calculated by manual tracing without the use of QLAB. Correspondingly, the Left Ventricular Ejection Fraction (EF) calculated using these applications may be higher than the EF calculated by manual tracing without the use of QLAB. Philips' investigation has found that this difference may occur in cases where the EF is less than approximately 40%. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/4/2015 |
